Palmdoc I User Manual
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Contents
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5413. Performance characteristicsPrecisionStandard deviation (SD) for each glucoseconcentration < 5.55 mmol/L and coefficient ofvariation (CV) for each glucose concentration≥ 5.55 mmol/L) is ≤ 0.278 mmol/L and ≤ 5.0%,respectively.Intermediate precisionControl Solution Level(mmol/L)Low(1.7~2.8)Normal(5.3~8.0)High(15.6~23.3)Pooled Mean (mmol/L) 2.5 5.6 19.6SD 3.0 3.0 8.1CV (%) - 3.0% 2.3%RepeatabilityBlood Glucose(mmol/L)1.7~2.82.9~6.16.2~8.38.4~13.914.0~22.2Pooled Mean(mmol/L)2.2 4.6 7.2 11.2 18.0SD 2.6 3.7 5.1 6.6 8.4CV (%) 6.5% 4.5% 3.9% 3.3% 2.6%System AccuracySystem accuracy results for glucoseconcentration <5.6 mmol/LWithin ±0.28mmol/LWithin ±0.56mmol/LWithin ±0.83mmol/L114/180 (63.3%) 172/180 (95.6%) 180/180 (100%)System accuracy results for glucoseconcentration ≥ 5.6 mmol/LWithin ±5% Within ±10% Within ±15%215/420 (51.2%) 336/420 (80.0%) 408/420 (97.1%)13. Performance characteristics |
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