[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.


CONCLUSIONS
This device, in the tested configuration, agrees the B grade of BHS and can be recommended for ambulatory blood pressure measurement.
de Gaudemaris
R
R
Service de médecine Interne et cardiologie, hôpital A-michallon, Grenoble.
White
A
A
Pascal
I
I
Siché
J P
JP
Baguet
J P
JP
Mallion
J M
JM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D015924:Blood Pressure Monitors; D005069:Evaluation Studies as Topic; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D008875:Middle Aged; D015203:Reproducibility of Results