User's Manual

About AM100 plus SMBG System
6
Intended Use
ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System is self-
test medical device and intended for home testing to monitor the blood
glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip
and venous whole blood. ACEZIN GLUGold AM100 plus Blood Glucose
Monitoring System is for In-vitro use only.
It is indicated to be used by diabetics at home or in a clinical setting by
professional healthcare personnel to measure the glucose concentration for
aiding diabetes management. The owner can only use AM100 plus
Blood Glucose Meter with AMG011 Blood Glucose Test Strips.
Measuring Principle
We design AM100 plus Blood Glucose Monitoring System by using the
latest biosensor technology. It measures the glucose levels of the blood
specimen by using a disposable dry reagent strip which can produce
an electrical current. And the current will transfer to the meter for
measurement. The amount of the current is proportional to the amount of
glucose present in the blood sample. Test results are “plasma equivalent”.
The system consists of three main products: AM100 plus Blood Glucose
Meter, AMG011 Blood Glucose Test Strips, and ACEZIN GLUGold
Control Solution. These products have been designed, tested, and proven to
work together and perform accurate results.
Note
The accuracy of AM100 plus Blood Glucose Monitoring System was
compared with YSI 2300 Analyzer.