UNLABELLED: 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.
UNLABELLED: 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.
Authors: Peter Bramlage; Cornelia Deutsch; Ralf Krüger; Andreas Wolf; Peter Müller; Thomas Zwingers; Beate Beime; Thomas Mengden Journal: Vasc Health Risk Manag Date: 2014-05-13