Pharma-Smart PS-2000 Proven Accuracy

The Pharma-Smart PS-2000 BP Monitor is designed to measure BP in accordance with American Heart Association (AHA) guidelines1 for general screening: seated, brachial artery measurement at the level of the heart.

The model PS-2000 oscillometric technology and unique cuff design has been clinically evaluated for compliance with The Association for the Advancement of Medical Instrumentation’s standard (AAMI) and to a modified British Hypertension Society (BHS) Protocol.2 The clinical study was performed at the University of Tennessee, and the results were published in the technical research journal Blood Pressure Monitoring (vol 9, no 1).

Subjects tested ranged in age from 18 to 74, with the average age of 40. Arm size ranged from 22 to 38 cm in circumference. Resting systolic BP ranged from 91 to 252 mmHg, and resting diastolic pressure ranged from 57 to 160 mmHg. There were 44 males, and 41 females. For each subject the readings obtained by the PS-2000 were compared with auscultatory readings obtained by two clinicians, blinded to the results of each other and the device. The manual reference measurements were alternated with the readings obtained by the device.

The study concluded: "The Pharma-Smart PS-2000 met the AAMI (FDA) requirements for accuracy. Most notably, the mean difference between well-trained clinicians and the device readings were very small (0.07 systolic and –0.3 diastolic). Further, when analyzed in accordance to the BHS evaluation protocol, the PS-2000 achieved the highest grade - an 'AA'. It is well suited for its role as a high volume, self-administered BP screening device."