User Manual

7
The Dario Glucose Control Solutions are for use with the Dario Blood Glucose
Meter and the Dario Blood Glucose Test Strips to check that the meter and test
strips are working together properly and that the test is performing correctly.
System Limitations
The Dario System should not be used for the following purposes:
The diagnosis of, or screening for, diabetes.
Testing the glucose levels of neonates (children younger than 4
weeks of age).
Testing glucose levels of arterial or venous blood.
Testing glucose from sites other than the fingertip.
Testing patients who are critically ill, in shock, or dehydrated.
If you are taking acetaminophen containing drugs (e.g. Tylenol) or
vitamin C (ascorbic acid) you may get inaccurate results with this
system. If you have a disease or condition in which uric acid levels in
your blood may be elevated (> 11 mg/dL), such as gout, you may get
inaccurate results with this system. If you have very high levels of
triglyceride (> 810 mg/dL), you may get inaccurate results with this
system. This system should not be used when undergoing xylose
absorption tests.
Important Safety Instructions
The meter and lancing device are for single-patient use. Do not share them
with anyone, including other family members. Do not use on multiple patients.
All parts of the kit are considered bio-hazardous and can potentially transmit
infectious diseases even after you have performed disinfection.
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