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increased emissions or decreased immunity of the de-
vice.
The device should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is
necessary, the device should be observed to verify
normal operation in the conguration in which it will be
used.
The basic performance is described in the table below:
Performance Description
Measurement accuracy
When the glucose concentration is
>4.2mmol/L (75mg/dL), the sensor
accuracy deviation does not exceed
±20%;
When the glucose concentration is
≤4.2mmol/L (75mg/dL), the accuracy
deviation does not exceed ±20mg/dL
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