Palmdoc II - Page 63

61
Owner’s Manual
• System Accuracy:
For glucose concentration < 5.6 mmol/L
Within ±0.28
mmol/L
Within ±0.56
mmol/L
Within ±0.83
mmol/L
106/180 (58.9%) 171/180 (95.0%) 180/180 (100%)
For glucose concentration ≥ 5.6 mmol/L
Within ±5% Within ±10% Within ±15%
201/420 (47.9%) 352/420 (83.8%) 410/420 (97.6%)
For glucose concentrations between 2.22 mmol/L and
28 mmol/L
Within ± 0.83 mmol/L or ±15 %
590/600 (98.3%)
The PalmDoc II Blood Glucose Monitoring System
meets the requirements for System Accuracy as
stated in ISO 15197:2013.
• User Performance:
A study evaluating glucose values from ngertip,
palm, forearm, upper arm, calf, and thigh
capillary blood samples obtained by 100 lay
persons showed the following results:
100% within ± 0.83 mmol/L of the medical
laboratory values at glucose concentrations
below 5.55 mmol/L, and ≥ 95% within ±15 %
Palmdoc 2 User Man.indd 61 24/08/2017 10:49