Evaluation of the Profilomat II ambulatory blood pressure system according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation.
OBJECTIVE
To evaluate the Profilomat II monitor for ambulatory blood pressure measurement according to the protocols of the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI).


METHODS
The BHS protocol is divided into two parts. Part I, which is the part applicable to this study, comprises the main validation procedure and has five phases: before-use device calibration; static device validation; and report of evaluation.


METHODS
Three Profilomat II recorders passed the before-use device calibration test. They then entered the in-use (field) assessment phase during which the three recorders were each worn by ten subjects for 24-h, after which the calibration was again assessed. Since no difference in calibration testing was observed between the three devices, one was selected randomly and the main validation test was carried out in 85 subjects, who had a wide range of blood pressures, using the sphygmocorder. The results were analysed according to the BHS grading system from A to D. The data was also analysed according to the standard of the Association for the Advancement of Medical Instrumentation (AAMI) which stipulates that the mean difference between the test device and the standard shall be </= 5 mmHg with a standard deviation of </= 8 mmHg.


RESULTS
The Profilomat II achieved a BHS grade C rating for systolic blood pressure and grade B for diastolic blood pressure; it satisfied the criteria for accuracy of the AAMI for diastolic but not systolic blood 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), the Profilomat II was less accurate in the high pressure range, achieving a D/C grading, and failed the AAMI criteria for systolic and diastolic blood pressures. The mean and standard deviation of the first mercury sphygmomanometer measurements were 145+/-34/87+/- 20 mmHg. Subject acceptability was good and the manufacturers manual was satisfactory.


CONCLUSIONS
On the basis of these results, the Profilomat II cannot be recommended for ambulatory blood pressure measurement in clinical practice where accurate measurements are required.
Mee
F
F
The Blood Pressure Unit, Beaumont Hospital, Dublin 9, Ireland.
Atkins
N
N
O'Brien
E
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology*; D001795:Blood Pressure Determination / Q000379:methods*; D018660:Blood Pressure Monitoring, Ambulatory; D006801:Humans; D006973:Hypertension / Q000503:physiopathology*; D008875:Middle Aged; D015203:Reproducibility of Results