- A hematocrit that is either very high (above 65%) or very low (below 20%) can cause false test results.
- Not for neonatal use.
- Dehydration may cause higher test results.
- The system has not been tested above 10,000ft.
- The Meter is designed for use only with Test Strips.
(manufactured by All Medicus Co., Ltd.)
- The Blood Glucose Monitoring System is calibrated to produce values equivalent to the
results on plasma specimens on a laboratory analyzer (YSI 2300 STAT Plus).
- The Blood Glucose Monitoring System should be used for 50~104
℉
(10~40
℃
).
- The Blood Glucose Monitoring System is for
in vitro
diagnostic use.
- Do not drop the meter.
- Do not disassemble, repair or remodel without consultation. The sensitive parts could be damaged
and the warranty will then become invalid.
- Handle all the reagents with care knowing that they are capable of transmitting infection.
- Used test strips, lancets and meter may be considered bio-hazardous waste in your area. Please contact
your health provider for instructions on how to discard them.
- The Blood Glucose Monitoring System are for single patient use only and for over the
counter use.
Carefully read and follow the instructions in the User Manual and package inserts for the test strips and
control solution and practice the testing procedures before using the Blood Glucose
Monitoring System. It is very important to follow the instructions in order to avoid an incorrect test
result that leads to improper therapy.
Take note of information and cautions throughout this User Manual.
This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices,
or long-term care facilities because it has not been cleared by FDA for use in these settings, including for
routine assisted testing or as part of glycemic control procedures.
Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
Precautions for Use
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