Prodigy VOICE Manual Del Propietário página 76

PRODIGY Voice® Blood Glucose Meter
2. The accuracy requirements for the blood
glucose monitoring system—meters and test
strips—as stated in ISO 15197 are:
Ninety-five percent (95%) of the individual
glucose results shall fall within ±15 mg/
dL (0.83 mmol/L) of the results of the
manufacturer's measurement procedure
at glucose concentrations < 75 mg/dL
(<4.2 mmol/L) and within ± 20% at glucose
concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L).
How does this answer the FAQ
The accuracy of the system is determined by a
clinical study using 100 blood samples at interval
glucose concentrations ranging from < 50 mg/
dL to over 400 mg/dL measured using both
the manufacturer's meter and a clinical blood
glucose analyzer for comparison (reference
measurement).
Example
If the manufacturer's reference measurement is 70
mg/dL this means that the meter measurements
are considered accurate if they fall within ± 15 mg/
dL of 70 mg/dL (from 55 mg/dL to 85 mg/dL).
Owner's Manual
76