Accuracy of the Takeda TM-2420/TM-2020 determined by the British Hypertension Society protocol.

Results: The three recorders passed the before-use interdevice variability assessment, after which 85% of inflations recorded with these devices during the in-use phase gave valid readings, and the three devices subsequently passed the after-use interdevice variability assessment. The main validation test was carried out in 86 subjects with a wide range of pressures, the results being analysed according to a grading system from A to D. The first Takeda TM-2420 achieved D rating for both systolic and diastolic pressures. The first Takeda used in the main validation test failed to function after testing in 36 subjects and had to be replaced. The Takeda TM-2420 failed to satisfy the criteria for accuracy of the Association for the Advancement of Medical lnstrumentation (AAMI), with an average difference @s.d.) of 4 f 11 and 2 f 11 mmHg for systolic and diastolic pressure, respectively. Subject acceptability was good. The manufacturer's manual was clear and reasonably comprehensive.