Checking Glucose with a Test Strip
Caution
Test on your fingers in accordance with the Intended Use.
Intended Use
The FreeStyle Libre 2 Reader's built-in meter is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes.
The FreeStyle Libre 2 Reader's built-in meter is indicated for the home (lay) user in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Libre 2 Reader's built-in meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Important
- Use only FreeStyle Precision Neo test strips. Other test strips may produce inaccurate results.
- Read all the instructions in this section. Failure to follow instructions may cause incorrect blood glucose results. Practice the testing procedures before using the Reader's built-in meter.
- Read the test strip instructions for use before performing your first blood glucose test as they contain important information. They also let you know how to store and handle the test strips and give you information about sample types.
- The Reader's built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
- The Reader's built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
- Follow your health care professional's advice when testing blood glucose levels.
- Severe dehydration (excessive water loss) may cause false low test strip results. If you believe you are suffering from dehydration, consult your healthcare professional right away.
- Inaccurate test strip results may occur in severely hypotensive individuals or patients in shock.
- Inaccurate test strip results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
- Observe caution when using around children. Small parts may constitute a choking hazard.
- You should clean and disinfect the Reader once per week. The Reader should also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user. Refer to the Maintenance and Disposal section of the Reader Kit User's manual for instructions.
- The Reader is for use by a single person. It must not be used on more than one person including other family members due to the risk of spreading infection. All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases, even after performing the cleaning and disinfection procedure.
- Use the Reader's built-in meter within the test strip operating temperature range (59˚F – 104˚F) or you will see Error Message E-1.
- Use a test strip immediately after removing from its foil packet.
- Only use a test strip once.
- Do not put urine on the test strip.
- Do not use expired test strips as they may cause inaccurate results.
- Do not use at altitudes higher than 10,000 feet above sea level.
- Do not use a wet, bent, scratched, or damaged test strip.
- Do not use the test strip if the foil packet has a hole or is torn.
- Results from the built-in meter are shown only in your Reader's Logbook and not in other history options.
- Refer to your lancing device instructions for use for how to use your lancing device.
- This device is not intended for use with multiple patients 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.
- After performing a blood glucose test, wash your hands with soap and water and thoroughly dry them.
- The built-in meter displays results from 20 - 500 mg/dL. Low or high blood glucose results can indicate a potentially serious medical condition.
Blood glucose results are marked on the results screen and in the Reader's Logbook with the 
symbol.
symbol.