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 ±3mmHg accuracy before and after 10 000 simulated cycles. Two trained observers (earing 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±8mmHg: -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.