Beurer GL 44 (mg/dL) User Manual download pdf (Page 36)

36 Beurer GL44 mg/dL

Result of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)

Within ±5 mg/dL

(Within ±0.28 mmol/L)

Within ±10 mg/dL

(Within ±0.56 mmol/L)

Within ±15 mg/dL

(Within ±0.83 mmol/L)

55/180 (30,6%) 111/180 (61,7%) 175/180 (97,2%)

Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)

Within ±5% Within ±10% Within ±15%

220/438 (50,2%) 357/438 (81,5%) 422/438 (96,3%)

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 GL44 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 con-

centrations <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 medi-

cal 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)

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Beurer GL 44 (mg/dL) User Manual Page 36