34 Beurer GL44 mg/dL
EMC
This device complies with the European standard EN 61326 and is subject to particular precautions
with regard to electromagnetic compatibility. Please note that portable and mobile HF communica-
tion systems may interfere with this unit. For more details, please contact our customer service at
the address indicated.
Test strip functionality
Test strips enable a quantitative measurement of the glucose level in fresh whole blood. When the gap
for taking blood comes into contact with a drop of blood, it is automatically filled by simple capillary
action. The blood is sucked into the absorbing gap on the test strip and the blood glucose monitor
measures the blood glucose level in the blood.
The test is based on the measurement of an electric current that is generated by the chemical reaction
of the glucose with the enzyme glucose dehydrogenase (Aspergillus sp.) on the strip.
During the reaction, a mediator transports electrons through the electrode surface and so gener-
ates a current.
The blood glucose monitor analyses this current. The current flow is proportional to the glucose con-
tent in the blood sample. The results are shown on the blood glucose monitor display. Only a small
amount of blood is required (0.6 microlitres) and measurement duration is approx. five seconds. 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 con-
trol 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 GL44 monitor corresponds to European guidelines IVD (98/79/EC) and MDD (93/42/EC).
Comparison of measured values with laboratory values
Performance characteristics: accuracy and precision
Whole blood glucose test results were compared to the YSI 2300 laboratory device. At a concen-
tration of < 75 mg/dL, ≥ 98 % were at +/-15 mg/dL, while at a glucose concentration of ≥ 75 mg/dL,
≥ 98 % were within 20 % of the reference values. The CV (coecient of variation) is < 5 %. The blood
glucose monitor is therefore comparable to a laboratory system.
