FED BGM-II, Руководство пользователя, Страница: 8 / 19

8
V.
V. V.
V. Test
Test Test
Test Performance
Performance Performance
Performance of
of of
of Blood
Blood Blood
Blood Glucometer
Glucometer Glucometer
Glucometer and
and and
and Blood
Blood Blood
Blood Glucose
Glucose Glucose
Glucose
Test
Test Test
Test Strip
Strip Strip
Strip
1. Test time
Test time of Blood Glucometer in each case is 10 seconds.
2. Test range
Test range of Blood Glucometer is 1.1mmol/L
～
33.3mmol/L
3. Measurement repeatability of Blood Glucometer and Blood Glucose Test
Strip
Precision of the repeated test results of Blood Glucometer and Blood
Glucose Test Strip should comply with the requirements in Table 1.
Table 1 Repeatability
4. System accuracy of Blood Glucometer and Blood Glucose Test Strip
For Blood Glucometer and Blood Glucose Test Strip, 95% of the deviation of
the test results should comply with the requirements in Table 2:
Table 2 Accuracy
Test Range Precision
＜
5.5mmol/L
（
<100mg/dL
）
Standard deviation SD
＜
0.42 mmol/L
（
<7.7 mg/dL
）
≥5.5 mmol/L
（
≥100 mg/dL
）
Coefficient of variation CV
＜
7.5%
Test Range Allowable deviation
≤4.2mmol
／
L(<75mg
／
dL) Not more than ±0.83mmol
／
L(±15mg
／
dL)
＞
4.2mmol
／
L(>75mg
／
dL) Not more than ±20
％