54
Beurer BGL60 mg/dL
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
0.05 – 0.19%
Salts
1.4%
Active ingredient for viscosity regulation 15.0%
Standards
The unit is for self-testing and conforms to the requirements of the European
Directive for Medical Devices, the MPG (German Medical Devices Act) and the
European standard EN 1060-1 (Non-invasive sphygmomanometers, Part 1: Gen-
eral requirements), EN 1060-3 (Non-invasive sphygmomanometers, Part 3: Sup-
plementary requirements for electro-mechanical blood pressure measuring
systems), EN 60601-1, 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 Ordi-
nance), regular metrology checks must be performed if the unit is to be used for
commercial or business 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
Blood sugar test results were compared with the YSI 2300 laboratory instrument.
For a concentration < 75 mg/dL,
≥
95% lay /- 15 mg/dL, while for a sugar
concentration
≥
75 mg/dL,
≥
98% 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.
