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Chemical composition of the control solution
The control solution is a red solution with a D-glucose content of less than 0.2%.
Ingredients
D-glucose
Salts
Substance for regulating viscosity
Controls
The Beurer BGL40 mg/dL monitor system for private use conforms to the EU
Medical Devices Directive, the German medical devices act (MPG) and European
standards EN1060-1 (non-invasive blood pressure monitors, Part 1: general
requirements) and EN1060-3 (non-invasive blood pressure monitors, Part 3:
supplementary 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 14971, EN ISO 15197, MDD (93/42/EC). In accordance with the German
Ordinance on the Installation, Operation and Use of Medical Devices, regular
measurement accuracy controls must be carried out if the machine is used for
commercial or business purposes. We also recommend testing the measurement
accuracy of devices in private use at two-yearly intervals by the manufacturer.
Comparing test results with laboratory results
Performance characteristics: accuracy and precision
Whole blood glucose test results have been compared with the YSI 2300 laboratory
analyzer. At a concentration <75 mg/dL ≥95% were +/-15 mg/dL, while at a glucose
concentration ≥75 mg/dL >98% were within 20% of the reference values. The CV
(coefficient of variation) (%) is <5%. The blood glucose monitor is therefore
comparable with a laboratory system.
Beurer BGL40 mg/dL
Percentage
0.05 – 0.19%
1.4%
15.0%
46
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