Validation of combiomed hipermax-BF model A7101 automatic oscillometric upper-arm sphygmomanometer in general population: AAMI/ESH/ISO universal standard (ISO 81060-2:2018/Amd 1:2020)
Bibliographic record
Abstract
This study evaluates the accuracy of the Hipermax-BF model A7101 (Combiomed, Havana, Cuba) automatic oscillometric upper-arm sphygmomanometer for office and home use in general population as part of the HEARTS in the Americas initiative. The research was developed according to the Universal Standard AAMI/ESH/ISO ISO 81060-2:2018/Amd 1:2020. The subjects were recruited according to the requirements of age, gender, blood pressure values and upper-arm circumference. The same upper-arm sequential blood pressure measurement method was used. For measurements with the device under test, the 2-piece cuff from 22-44 cm limb circumference range was used. 92 subjects were recruited and 85 were analyzed. Mean age was 44.8 ± 14.7 years, mean upper-arm circumference was 32.3 ± 6.2, and 56.5% were female. For Validation Criterion 1, the mean value ± standard deviation of the differences in readings between the device under test and the reference device was 1.2 ± 4.9/0.8 ± 4.9 mmHg (systolic/diastolic). For both pressures, in criterion 1 the standard requires a mean value of the differences ≤ ± 5 mmHg and a standard deviation ≤ ± 8 mmHg. For Validation Criterion 2, the standard deviation of the mean blood pressure differences per subject was 4.2/4.2 mmHg (systolic/diastolic). According to Table 1 of criterion 2, for the mean values of 1.2/0.8 mmHg (systolic/diastolic), the maximum allowable standard deviation had to be < 6.84 for systolic and < 6.89 for diastolic pressure. The Combiomed Hipermax-BF A7101 automatic sphygmomanometer meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018/Amd 1:2020) in the general population.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".