Beurer medical GL 44, Инструкция по эксплуатации

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32 Beurer GL44
Results of the intermediate precision measurement
Sample Control material Grand mean value Pooled standard
deviation
Pooled coefficient
of variation (%)
mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L
1 70.0 3.9 71.3 4.0 1.0 0.1 1.4
2 135.6 7.5 136.3 7.6 1.4 0.1 1.1
3 351.5 19.5 350.8 19.5 2.8 0.2 0.8
System accuracy
The GL44 blood glucose monitor in comparison to the YSI.
Three lots of GL44 blood glucose test strips have been tested to assess the system accuracy of the
GL44 blood glucose measuring system and to compare it with the reference method in which capillary
whole blood concentrations of 36.0 mg/dL (2.0 mmol/L) to 442.5 mg/dL (24.6 mmol/L) have been used.
Results of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
101/168 (60.12%) 161/168 (95.83%) 166/168 (98.81%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5% Within ±10% Within ±15%
182/432 (42.13%) 358/432 (82.87%) 426/432 (98.61%)
Results of the system accuracy for combined glucose concentrations between 36.0 mg/dL
(2.0 mmol/L) and 442.5 mg/dL (24.6 mmol/L).
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
592/600 (98.67%)
In comparison to the YSI, the GL44 met the EN ISO 15197:2015 standard, whereby 95% of the blood
glucose values measured have to fall within the following zones: either ±15 mg/dL (± 0.83 mmol/L)
of the measured average values when using the reference measuring procedure for blood glucose
concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/dL
(≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A and
B of the Consensus Error Grid (CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips, which
were obtained from 103 individuals that had no special training, produced the following results:
96.7% within ±15 mg/dL (±0.83 mmol/L) and 95.9% within ±15% of the values obtained in the med-
ical laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).