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 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 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.     

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   

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 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 Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension

BACKGROUND: There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. OBJECTIVE: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). RESULTS: The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. CONCLUSIONS: According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.     

Validation of the Artsana CS 410 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension

BACKGROUND: Electronic blood pressure monitoring devices are widely used by patients for monitoring their blood pressure at home. Few of them, however, have been validated against recognized protocols and proved to be accurate. OBJECTIVE: This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device, Artsana CS 410 (Artsana S.p.A., Grandate, Como, Italy), complied with the standard of accuracy indicated by the European Society of Hypertension (ESH) International Protocol. METHODS: Sequential measurements of systolic and diastolic blood pressure were obtained in 33 patients (13 males, 20 females, mean age+/-SD 49+/-12 years) using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always used during the study. According to the ESH validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs of measurements for each of the 33 patients). RESULTS: The Artsana CS 410 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg, never <40 within 10 mmHg and never <42 within 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -0.9+/-5.9 mmHg for systolic and -1.0+/-3.1 mmHg for diastolic blood pressure. CONCLUSION: According to the results of the validation study, based on the ESH International Protocol, the Artsana CS 410 may be recommended for clinical use in adults.     

Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults

BACKGROUND: Electronic blood pressure (BP) measurement devices are the preferred choice of patients owing to their user-friendly nature; however, there is a requirement to investigate the accuracy and reliability of these devices. The objective of this study is to evaluate the accuracy of the Omron M6 upper-arm BP device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. METHODS: One hundred and twenty-one patients, older than 30 years of age, were studied and classified on the basis of the range of the International Protocol. 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. A total of 33 participants were selected for each validation study. During the validation study, 99 measurements were performed on 33 participants for comparison. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Having a two-fold purpose, this study was conducted on both adult and obese adult patients. RESULTS: Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.1+/-4.0 mmHg for systolic BP (SBP) and -0.5+/-3.5 mmHg for diastolic BP (DBP) in the adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 88, 96, and 97 for SBP, and 88, 98, and 99 for DBP were <5, <10, and <15 mmHg, respectively. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.7+/-4.8 mmHg for SBP and -0.8+/-4.3 mmHg for DBP in the obese adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 82, 90, and 97 for SBP, and 80, 97, and 99 for DBP were <5, <10, and <15 mmHg, respectively. It was found that the Omron M6 automatic monitor, which measures BP at the upper arm, produced results in accordance with the criteria of phases 2.1 and 2.2 in both SBP and DBP, when applied to adults and to obese adults. CONCLUSION: It was concluded that the Omron M6 device, which measures BP at the upper arm, was deemed to be in accordance with the International Protocol criteria and can be recommended for use by adults and obese adults.     

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 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.     

Validation of the OMRON M7 (HEM-780-E) blood pressure measuring device in a population requiring large cuff use according to the International Protocol of the European Society of Hypertension

BACKGROUND: A high percentage of hypertensive patients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. DESIGN: A validation study was performed according to the International Protocol of the European Society of Hypertension. This protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood-pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood-pressure measurements), making a total number of 33 participants (99 pairs of blood-pressure measurements), on whom the analysis is performed. METHODS: For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (相似文献   

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

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

Validation of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults

BACKGROUND: We evaluated the clinical validity of the AGILIS ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol. METHODS: The blood pressure (BP) was measured at the same arm by two certified observers using two mercury columns and a double stethoscope, then by the volunteer with the automatic device, these measurements were done seven times sequentially using 33 volunteers. For the randomization of the patient, one ABPM measure was compared to the mean of three manual measures. Then, we had three ABPM measures and four manual measures. Each ABPM measure, being compared to two manual measures. Blood pressure readings and recordings were blinded. Position of the subjects was standardized. RESULTS: Phase 1: To pass phase 1, the device had to have at least 25 of the 45 measurements within 5 mmHg, 35 within 10 mmHg or 40 within 15 mmHg of the comparative observer measurements. The AGILIS monitor had 35 measurements lying within 5 mmHg, 42 within 10 mmHg and 45 within 15 mmHg for systolic BP (SBP), 35 within 5 mmHg, 44 within 10 mmHg and 45 within 15 mmHg for diastolic BP (DBP). It passed the criteria for SBP and DBP. Phase 2: To pass phase 2.1, a device must have at least 60 of 99 measurements within 5 mmHg, 75 within 10 mmHg and 90 within 15 mmHg of the comparative observer measurements, and in addition must also have either 65 within 5 mmHg and 80 within 10 mmHg, or 65 within 5 mmHg and 95 within 15 mmHg, or 80 within 10 mmHg and 95 within 15 mmHg. The AGILIS monitor had 78 measurements within 5 mmHg, 91 within 10 mmHg and 96 within 15 mmHg for SBP; and 70 measurements within 5 mmHg, 92 within 10 mmHg and 96 within 15 mmHg for DBP. It passed the criteria for SBP and DBP. For phase 2.2 using the AGILIS monitor, 27 subjects had at least two of the differences within 5 mmHg and none had any differences within 5 mmHg for SBP; 27 subjects had at least two of the differences within 5 mmHg and three subjects had no differences within 5 mmHg for DBP. The results are in concordance with the requested criteria for phase 2.2. CONCLUSION: Thus the AGILIS device fulfils the validation criteria of the international protocol.     

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

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

Validation of the ROSSMAX blood pressure measuring monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults

BACKGROUND: It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the ROSSMAX Blood Pressure Measuring Monitor for self-measurement according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper. POPULATION: Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland. METHODS: The ROSSMAX monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder. RESULTS: In phase 1, the ROSSMAX monitor produced 21 measurements within 5 mmHg, 31 within 10 mmHg and 38 within 15 mmHg for systolic blood pressure (SBP), and 36 within 5 mmHg, 43 within 10 mmHg and 45 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -5.6 (10.2) [mean (SD)] mmHg for SBP and -0.5 (4.5) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.1, the ROSSMAX monitor had 51 measurements within 5 mmHg, 73 within 10 mmHg and 86 within 15 mmHg for SBP, and 71 measurements within 5 mmHg, 93 within 10 mmHg and 98 within 15 mmHg for DBP. The mean differences were -4.5. (9.5) mmHg for SBP and -1.8 (5.0) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.2, 16 subjects had at least two of the differences lying within 5 mmHg and 10 subjects had no differences within 5 mmHg for SBP; 26 subjects had at least two of the differences falling within 5 mmHg and three subjects no differences within 5 mmHg for DBP. The ROSSMAX monitor failed to meet the criteria for SBP but passed the criteria for DBP. CONCLUSIONS: The ROSSMAX monitor cannot be recommended for clinical use in an adult population because it records SBP inaccurately.