10 c – Beurer GL 50 evo (mgdl) User Manual

Page 35

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Beurer GL50 evo mg/dL

35

Only a small amount of blood is required (0.6 microlitres) and measurement takes approx. five sec-

onds. The test strip detects blood glucose values from 20 to 630 mg/dL.

Chemical components of the test strip sensor
• FAD glucose dehydrogenase 6%

• Potassium ferricyanide

56%

• Non-reactive components

38%

Control solution functionality
The control solution contains a fixed amount of glucose that reacts with the test strip. A test with

control solution is similar to a blood test. However, control solution is used instead of blood. The

measured result using control solution must be within the result range. This range is printed on each

test strip box.

Chemical composition of the control solution
The control solution is a red solution with the following D-glucose level (in percentage shares):
Ingredients

Control solution LEVEL 3

Control solution LEVEL 4

D-glucose 0.14% 0.37%

Non-reactive components

99.86%

99.63%

Standards
The Beurer GL50 evo blood glucose monitor complies with the European standards: IVD (98/79/EC)

and MDD (93/42/EC).

10 c

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Precision
Three lots of the GL50 evo blood glucose test strips have been tested to assess the precision of the

GL50 evo blood glucose measuring system. This includes a repeat assessment using venous blood

and a laboratory precision assessment using the control material. The blood glucose content of the

venous blood samples ranges from 42.7 to 418.0 mg/dL and control material from three concent-

rations is used.

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