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.