Validation of the Pharma-Smart PS-2000 public use blood pressure monitor

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Abstract

Objective

To test the Pharma-Smart Model PS-2000 public use blood pressure monitor for compliance with the Association for the Advancement of Medical Instrumentation's Standard (AAMI) and to a modified British Hypertension Society (BHS) Protocol.

Methods

Subjects tested ranged in age from 18–74, with the average age of 40. Arm circumference ranged from 22–38 cm. Resting systolic blood pressure (BP) ranged from 91–252 mmHg, and resting diastolic pressure ranged from 57–160 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.

Results

The average differences between the reference readings (average of the two clinicians) using the AAMI analysis and the automated readings were 0.07±7.0 mmHg (Mean±SD) for systolic BP, and −0.3±6.6 mmHg for diastolic BP.

Conclusions

The device met the accuracy requirements of the AAMI standard. In addition, when the data were analyzed to assess the compliance with the current British Hypertension Society Protocol (BHS), the device earned the highest rating of ‘A’ for both systolic and diastolic pressure. We believe that the Pharma-Smart PS-2000 will provide valid readings when placed in non-medical public use sites.

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