Manual Beurer GL 50 evo mmol (page 36 of 40) (Italian)

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36 Beurer GL50 mmol/L

Risultati delle misurazioni della precisione intermedie

Campione Valore medio complessivo

materiale di controllo (mg/dL)

Scostamento stan-

dard aggregato

Coeciente di varia

zione aggregato (%)

1 4,3 2,1 2,7

2 7,4 2,5 1,9

3 18,8 8,1 2,4

Precisione del sistema

Il misuratore di glicemia GL50 a confronto con YSI.

Sono state testate tre strisce reattive del GL50 per valutare la precisione del sistema di misurazione

della glicemia GL50 e per confrontarlo con i metodi di riferimento utilizzando concentrazioni di san

gue intero capillare da 1,8 a 28,4 mmol/L.

Risultati per la precisione del sistema con concentrazioni di glucosio <100 mg/dL (<5,55 mmol/L)

Entro ±5 mg/dL

(Entro ±0,28 mmol/L)

Entro ±10 mg/dL

(Entro ±0,56 mmol/L)

Entro ±15mg/dL

(Entro ±0,83 mmol/L)

121/204 (59,3%) 183/204 (89,7%) 201/204 (98,5%)

Risultati per la precisione del sistema con concentrazioni di glucosio ≥100 mg/dL (≥5,55 mmol/L)

Entro ±5% Entro ±10% Entro ±15%

242/474 (51,5%) 404/474 (85,2%) 462/474 (97,5%)

Risultati per la precisione del sistema per concentrazioni di glucosio combinate comprese

tra 32,4 mg/dL (1,8 mmol/L) e 511,8 mg/dL (28,4 mmol/L).

Entro ±15 mg/dL o ±15%

(Entro ± 0,83 mmol/L o ±15%)

663/678 (97,8%)

GL50 in confronto con YSI soddisfa la norma EN ISO 15197:2013 secondo la quale il 95% dei valori

glicemici misurati deve essere compreso nei seguenti range: ± 0,83 mmol/L (±15 mg/dL) dei valori

medi misurati con utilizzo del processo di misurazione di riferimento con concentrazioni di glucosio

<100 mg/dL (<5,55 mmol/L) o ±15% con concentrazioni di glucosio ≥100 mg/dL (≥5,55 mmol/L).

Il 99% dei singoli valori di glicemia misurati deve essere all’interno dei livelli A e B della Consensus

Error Grid (CEG) per il diabete di tipo 1.

Valutazione delle prestazioni da parte dell’utente

Uno studio sulla valutazione dei valori glicemici di campioni di sangue prelevati dalla punta del dito

da 113 persone senza una preparazione speciﬁca ha fornito i seguenti risultati:

il 97,1% entro ±15 mg/dL (±0,83 mmol/L) e il 95,6% entro ±15% dei valori ottenuti in un laboratorio

medico con concentrazioni di glucosio minime pari a 100 mg/dL (5,55 mmol/L).

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Others manual(s) of Beurer GL 50 evo mmol

Beurer GL 50 evo mmol User Manual - English - 40 pages

Beurer GL 50 evo mmol User Manual - German - 44 pages

Beurer GL 50 evo mmol User Manual - Dutch - 40 pages

Beurer GL 50 evo mmol User Manual - French - 40 pages

Beurer GL 50 evo mmol User Manual - Spanish - 40 pages

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Beurer GL 50 evo mmol Manual

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