28
Beurer GL42 mg/dL
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 10%
• Potassium ferricyanide
46%
• Non-reactive components
44%
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 5
Control solution LEVEL 6
D-glucose
0.12% 0.35%
Non-reactive components
99.88% 99.65%
Standards
The Beurer GL42 monitor corresponds to European guidelines IVD (98/79/EC) and
MDD (93/42/EC).
11. c
omparison
of
measured
values
with
laboratory
values
Precision
Three lots of the GL42 blood glucose test strips have been tested to assess the precision of the GL42
blood glucose measuring system. This includes a repeat assessment using venous blood and a labora-
tory precision assessment using the control material. The blood glucose content of the venous blood
samples ranges from 44.9 to 362.3 mg/dL and control material from three concentrations is used.
Results of the repeat precision measurements
Sample
Venous blood
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard de-
viation
Pooled coefficient
of variation (%)
1
44.9
44.8
3.2
7.1
2
90.6
94.1
3.2
3.5
3
120.0
114.9
3.2
2.8
4
225.8
212.1
6.9
3.2
5
362.3
347.0
11.2
3.2
Содержание GL42
Страница 2: ......
Страница 31: ...Beurer GL42 mg dL 31...
Страница 32: ...751 178 0314_GL42_mg dL_GB Subject to errors and changes...
