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Vers. 20210510ENG Page 32
This product belongs to professional IVD equipment and needs to pay attention to the
following preventive warnings:
❖ The emission and immunity requirements specified in Tables 1 to 4 shall be met.
❖ It is recommended to evaluate the electromagnetic environment prior to use.
❖ Do not use this equipment near strong radiation sources (such as unshielded RF
sources), as this may interfere with normal operation of the equipment.
Basic performance
The equipment should work normally, and the bias of glucose (GLU) test results should meet
the requirements of 2.3 in the technical requirements.
Test method
Three measurements were made on the same quality control sample of GLU, and the
allowable error was calculated according to the method listed in 3.3 in the technical
requirements.
8.1.1 Operating Mode
Normal test mode: The device is powered on, and the GLU accuracy reagent disk is loaded
for normal testing.
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