Validation of Heine Gamma G7 (G5) and XXL-LF aneroid devices for blood pressure measurement

Objective To determine the accuracy of the Gamma G7 (and G5 model) and XXL-LF aneroid sphygmomanometers developed by the Heine Company. Design Device evaluations were performed using the new protocol of the European Society of Hypertension. Monitor performance was assessed in relation to participants' sex, age, arm circumference, and systolic and diastolic blood pressures. Methods The two sphygmomanometers were assessed in two different samples according to European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. Results Both sphygmomanometers passed all three phases of the protocol for systolic blood pressure and diastolic blood pressure. Mean blood pressure difference between Gamma G7 sphygmomanometer and observers was -0.4 +/- 3.3 mmHg for systolic blood pressure and - 0.5 +/- 2.6 mmHg for diastolic blood pressure. Mean differences for the Gamma XXL-LF sphygmomanometer were - 0.3 +/- 3.7 and - 1.0 +/- 2.6 mmHg, respectively. In multivariable analyses, the SBP discrepancies between both aneroid sphygmomanometers and observers were unrelated to age, sex, arm circumference and systolic blood pressure. For diastolic blood pressure, a borderline relationship was found only for arm circumference (P=0.057) with the Gamma G7 device. Conclusions These data show that the Heine Gamma G7 and Gamma XXL-LF aneroid sphygmomanometers satisfy the new recommended ESH accuracy levels for both SBP and DBR Their performance is uniform across subgroups of participants with different clinical characteristics.