Beurer GL - Page 34

34 Beurer GL44 mmol/L
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 concentra-
tion of < 4.2 mmol/L, ≥ 98 % were at +/-0.8 mmol/L, while at a glucose concentration of ≥ 4.2 mmol/L,
≥ 98 % were within 20 % of the reference values. The CV (coecient of variation) is < 5 %. The blood
glucose monitor is therefore comparable to a laboratory system.
You will find further details and information regarding blood glucose results and various technologies
in generally relevant specialist medical literature.
Usage limits for specialist personnel from the healthcare sector:
1. If the patient shows the following symptoms, it may be the case that no correct values can be
displayed:
 •Acutedehydration
 •Acutehypotension(lowbloodpressure)
 •Shock
 •Hyperosmolarhyperglycaemiccondition(withorwithoutketosis)
2. Lipaemic samples: cholesterol levels up to 13 mmol/L and triglycerid levels up to 11.4 mmol/L do
not influence the results. Severely lipaemic blood samples were not tested with the Beurer GL44
blood glucose monitor; therefore, using the device with these samples is not recommended.
3. In the case of severely ill patients, blood glucose monitors for home use should not be used.
4. The influence of interfering substances on the measurements depends on the concentration in
the blood. The maximum concentrations of certain substances listed below do not significantly
influence the measurements.
Concentration
of tested substances
4.4 mmol/L 6.7 mmol/L 27.8 mmol/L
Ascorbic acid, 0.23 mmol/L
10.9% -1.8% 4.6%
Ibuprofen, 2.42 mmol/L 3.1% 2.9% 4.6%
L-dopa, 0.09 mmol/L
10.6% 7.9% 4.9%
Blood glucose
value
Influence