User's Manual

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Precision:
Repeatability evaluation for venous blood samples.
Intermediate evaluation for control solutions.
Mean (mg/dL)
CV (%)
45.0
3.1
84.7
2.1
130.8
2.2
206.2
2.6
341.8
2.4
Mean (mg/dL)
CV (%)
49.7
2.3
100.5
1.7
300.3
0.7
Test results of VENTRAL HAND were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
4/5 (60%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
111/145(77%)
Within ± 10mg/dL
143/145 (99%)
Within ± 15mg/dL
145/145 (99%)
Within ± 20mg/dL
145/145(100%)
Test results of UPPER ARM were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
4/5 (80%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ±5%
1.9/145(75%)
Within ±10%
143/145 (99%)
Within ±15%
145/145 (100%)
Within ±20%
145/145(100%)
Test results of FORE ARM were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
4/5(80%)
Within ± 10mg/dL
5/5 (100 %)
Within ± 15mg/dL
5/5 (100 %)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ±5%
95/145(66%)
Within ±10%
137/145 (94%)
Within ±15%
143/145 (99%)
Within ±20%
145/145(100%)
Test results of THIGH were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
3/5(60%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
103/145(71%)
Within ±10%
137/145 (94%)
Within ±15%
144/145 (99%)
Within ±20%
145/145(100%)
Test results of CALF were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
2/5(40%)
Within ± 10mg/dL
5/5 (100 %)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ±5%
100/145(69%)
Within ±10%
138/145 (95%)
Within ±15%
145/145 (100%)
Within ±20%
145/145(100%)