Beurer GL 50 evo (mgdl) User Manual download pdf (Page 37)

Beurer GL50 evo mg/dL 37

Results of the system accuracy for combined glucose concentrations between 34.4 mg/dL

(1.9 mmol/L) and 442.8 mg/dL (24.6 mmol/L).

Within ±15 mg/dL or ±15%

(Within ±0.83 mmol/L or ±15%)

597/618 (96,6%)

In comparison to the YSI, the GL50 evo met the EN ISO 15197:2013 standard, whereby 95% of the

blood glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/

dL) of the measured average value when using the reference measuring procedure for blood glucose

concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/

dL (≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A

and B of the Consensus Error Grid (CEG) for diabetes type 1.

Performance evaluation by the user

A study to assess the glucose values of blood samples of capillary blood from the ﬁngertips, which

were obtained from 103 individuals that had no special training, produced the following results:

96.7% within ±15 mg/dL (±0.83 mmol/L) and 95.9% within ±15% of the values obtained in the me

dical laboratory with glucose concentrations of at least 100 mg/dL (5.55 mmol/L).

You will ﬁnd further details and information regarding blood glucose results and various technologies

in generally relevant specialist medical literature.

11 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 500 mg/dL and triglycerid levels up to 1000 mg/dL do

not inﬂuence the results. Severely lipaemic blood samples were not tested with the Beurer GL50

evo 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 in-

ﬂuence the measurements.

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Beurer GL 50 evo (mgdl) User Manual Page 37