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2 Safety Information
2.1 Application definition
The device is intended for continuous or periodic recording of glucose levels in
interstitial fluid for adult patients with diabetes aged 18 or older. The information is
intended to support, rather than to replace standard glucose monitor and is intended
for detecting trends and track pattern to provide reference information for patients to
better manage diabetes. The system provides real-time blood glucose value, which
is received and displayed by the App. The blood glucose value data can be further
imported into the software for analyzing historical blood glucose values.
Apply site
：
Abdomen
Frequency of data interaction:
Once every 3mins
Reuse:
Sensor is disposable
；
The transmitter can be reused up to 3 years.
Warning
CGMS(i3) does not provide any medical advice and cannot be used for such
purpose. Do not adjust your treatment plan without discussing it with your
medical diabetes team.
2.2 Important user information
In order to use this product safely, please review your product instructions before
using your Continuous Glucose Monitoring System. The instructions include
contraindications, warnings, cautions, and other important user information. Discuss
with your doctor how to use the information to help you control your blood glucose.
The instruction manual contains important information about system
troubleshooting and equipment performance characteristics.
2.3 Contraindications
Part of the sensor shall pierce the skin, so it is recommended that people with
delicate skin use the device cautiously. The product must be removed before you
undergo magnetic resonance imaging (MRI).
Intake of acetaminophen while wearing the sensor may falsely raise your sensor
glucose readings.
2.4 Warning
Read the instructions thoroughly. incorrect use of the continuous blood glucose
monitoring system may lead to misunderstanding of the information provided
