LUNA
25 GLU

Description
Test strips for blood glucose measurement.
Wellion LUNA blood glucose test strips are intended for measuring blood glucose levels in whole blood for self-monitoring with Wellion LUNA series meters at home and in clinical settings by healthcare professionals (in-vitro diagnostics).
Wellion LUNA blood glucose test strips use electrochemical biosensor technology. A whole blood sample is automatically drawn into a reaction zone on the strip by capillary action, resulting in a stable sample volume. When glucose in the whole blood sample reacts with the reagent on the electrodes, Wellion LUNA series meters detect a current when a fixed potential is applied between the electrodes. The current is then converted into a blood glucose concentration reading.

Instructions for use
Sample collection procedures
A fresh capillary blood sample is required for use with Wellion LUNA blood glucose test strips. To ensure accurate results each time you test your blood glucose levels, follow the recommended procedures for obtaining a blood sample:
- clean the chosen test site with warm soapy water, then rinse and dry thoroughly;
- if using an alcohol swab, ensure the puncture site is completely dry before proceeding;
- puncture the chosen site to draw blood. After wiping away the first drop of blood, you can gently massage or rub the area to collect the necessary amount of blood. Do not press excessively on the puncture site;
- to obtain a sufficiently large drop of blood, you can adjust the lancing device to a deeper setting.

How to perform the test
1. Remove one strip from the vial and immediately recap it.
2. Firmly insert the strip into the meter, which will automatically turn on.
3. Verify that the GLUC test mode symbol is at the top of the meter's LCD screen. If the test mode is not GLUC, insert a new strip.
4. Use the lancing device to obtain a correctly sized drop of blood. Refer to the user manual or instructions for finger-pricking.
5. The meter displays the blood drop symbol on the screen; gently touch the blood sample with the tip of the strip. The blood sample will be drawn into the strip's reaction area. When enough blood is present, the countdown will begin after an audible signal from the meter.
6. Read the test result when the countdown is complete. The result will be stored in the meter's memory.
7. Remove the strip from the meter, which will automatically turn off. The meter will also automatically turn off after 3 minutes of inactivity.

Expected results
Wellion LUNA series meters display blood glucose test results from 20 mg/dL (1.1 mmol/l) to 600 mg/dL (33.3 mmol/l). Expected blood glucose values for people without diabetes:
- generally, the fasting glucose level for a non-diabetic adult is 70-105 mg/dL (3.9-5.8 mmol/l) before breakfast and 70-110 mg/dL (3.9-6.1 mmol/l) before lunch or dinner;
- one and two hours after meals, normal blood glucose should be between 120-160 mg/dL (6.7-8.9 mmol/l) respectively;
- between 2 and 4 AM, blood glucose should be above 70 mg/dL (3.9 mmol/l).

Unexpected or uncertain results
Blood glucose levels that are too low or too high could be symptomatic of serious diseases. If the blood glucose value is unusually high or low or does not reflect your subjective well-being, repeat the test with a new test strip. If the detected value does not conform to your well-being or if the blood glucose result is below 70 mg/dL (3.9 mmol/l) or above 180 mg/dL (10.0 mmol/l), you should contact your healthcare provider and follow therapeutic suggestions. If test results are unusual or inconsistent, check the following:
- verify that the test strips have not expired;
- check the performance of the meter and test strips by performing a control solution test;
- verify that the blood sample completely fills the test area of the test strip.

Warnings
1. Consult your doctor or healthcare provider before making any therapeutic changes based on test results obtained with the Wellion LUNA series meter.
2. For using Wellion LUNA blood glucose test strips with Wellion LUNA meters, it is recommended to collect whole blood from the fingertip.

Precautions
1. This system is for in-vitro diagnostics only.
2. Test strips of other brands are not approved for use with Wellion LUNA series meters; using test strips other than Wellion LUNA blood glucose test strips may generate inaccurate results.
3. Potential biological hazard. Healthcare professionals and others using this system on multiple individuals must be aware that all products or materials exposed to human blood can potentially transmit viral diseases, even after cleaning.
4. Do not use a Wellion LUNA series meter to perform a test until the control solution test result is within the control range. The system is not working correctly if you continue to get control solution test results outside the range.

Limitations
Observe the following limitations to obtain accurate blood glucose test results with Wellion LUNA series meters and the strip:
- for in-vitro diagnostics only (for external use only);
- do not expose test strips to high humidity or direct sunlight. Do not freeze the strips;
- Wellion blood glucose test strips are for single use only, do not reuse;
- handle the strip with clean, dry hands; thoroughly clean and dry the puncture site for testing;
- do not test with a mobile phone in use nearby; avoid electronic signal interference.;
- high altitude effect: Wellion blood glucose test strips can be used at altitudes up to 3048 m without affecting test results. ;
- hematocrit (Hct) range between 25-60% is acceptable. Hct below 25% may generate elevated results. Hct above 60% may generate reduced blood glucose values compared to the whole blood reference;
- Wellion LUNA blood glucose test strips have not been validated for testing neonatal blood samples. Do not use test strips for testing on neonates;
- the test strips react only with D-glucose and not with other sugars that may be present in the blood.

Components
Glucose oxidase: >5 units (Aspergillius Niger).
Other components (buffers, mediator, surfactant, stabilizer, etc.): >0.2 mg Storage
Store at room temperature between 4-30 °C (39-86 °F). Do not expose directly to sunlight and heat. After removing a strip, immediately close the vial. Use the strip immediately after removing it from the vial. Always store test strips in their original vial. Do not bend, cut, or curve the strips. Handle, remove, touch, and insert the strip gently with clean, dry hands.

Code WELL612