Background: Accurate blood pressure measurement is critical to successful care of the hypertensive patient. The mercury manometer is rapidly being removed from clinical practice due to concerns about environmental contamination. The Accoson Greenlight 300 device is the first non-automated mercury-free device for auscultatory blood pressure measurement to pass the International Protocol for validation of blood pressure measuring devices in adults.
Methods: Fifty-one patients were enrolled to obtain the 33 patients required to fill the three systolic blood pressure (SBP) ranges (low 90-129 mmHg, medium 130-160 mmHg, high 161-180 mmHg) and diastolic blood pressure (DBP) ranges (low 40-79 mmHg, medium 80-100 mmHg, high 101-130 mmHg). Nine sequential blood pressure measurements by two observers with the mercury manometer and the supervisor with the Greenlight 300 were taken. The first two observer blood pressures were used to classify the SBP and DBP range. The readings were then analyzed in two phases to determine whether the device passed the International Protocol.
Results: The device passed Phase 1 using 15 subjects. In Phase 2.1 (n=33) for the 99 readings of SBP, 84 of 99 were within 5 mmHg, 95 of 99 were within 10 mmHg, and 98 of 99 were within 15 mmHg. For the 99 readings of DBP, 74 of 99 were within 5 mmHg, 90 of 99 were within 10 mmHg, and 96 of 99 were within 15 mmHg. In Phase 2.2 (n=33) for SBP, 33 of 33 had 2 of 3 SBP within 5 mmHg and none had all three readings >or=5 mmHg. For DBP, 27 of 33 had 2 of 3 of their DBP within 5 mmHg and only three had all three readings > or =5 mmHg.
Conclusions: The Accoson Greenlight 300 is the first electronic non-automated blood pressure measurement device to pass the International Protocol.