Beurer GL40 (mmol/L) Инструкция по эксплуатации онлайн [37/40] 54834

Beurer GL40 (mmol/L) Инструкция по эксплуатации онлайн [37/40] 54834
Beurer GL40 mmol/L 37
Note regarding function of the control solution
The control solution contains a fixed concentration of glucose that reacts with the test
strip. A test with the control solution is performed in the same way as a blood test, but the
control solution is used instead of blood. The measurement result from the control solu-
tion must lie within the results range. This results range is printed on every test strip con-
tainer.
Chemical composition of the control solution
The control solution is a red-coloured solution with a D-glucose content of less than 0.2%.
Ingredient Percentage concentration
D-glucose 0.12 %
Non-reactive components 99.88%
Standards
The Beurer GL40 measuring system for household use corresponds to the following Eu-
ropean directives and standards:
IVD (98/79/EC), EN 61010-1, EN 61010-2-101, EN 13640, EN ISO 15197,
MDD (93/42/EC).
In accordance with the MPBetreibV (German Medical Device Operator Ordinance), regu-
lar metrology checks must be performed if the unit is to be used for commercial or busi-
ness purposes. For private use, we also recommend having the manufacturer perform a
metrology check every 2 years.
Comparison between measured values and laboratory values
Performance characteristics: Accuracy and precision
Whole blood sugar test results were compared with the YSI 2300 laboratory instrument.
For a concentration < 4,2 mmol/L, 95% lay within +/- 0,8 mmol/L, while for a sugar con-
centration 4,2 mmol/L, 95% lay within 20% of the reference values.The CV (variation
coefficient) is < 5 %. The blood sugar measuring device is therefore comparable with a
laboratory system.
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