LUNA
25 GLU

Description
Reactive strips for measuring blood sugar.
The reactive blood glucose measurement strip Wellion LUNA is expected to measure blood glucose values in the whole blood for self-control with the gauges of the Wellion LUNA series at home and at clinical sites by healthcare professionals (in-vitro diagnostics).
The reactive strip for blood glucose measurement Wellion LUNA uses electrochemical biosensor technology. A whole blood sample is automatically taken to a strip reaction zone by acting on a capillary, obtaining a stable sample volume. When glucose in the whole blood sample reacts with the reagent on electrodes, the Wellion LUNA series meters detect a current to the application of a fixed potential among electrodes. The current is then converted into a reading of the glycemic concentration.

Mode of use
Procedures for sampling
A fresh capillary blood sample is required to be used with reactive strips for the measurement of Wellion LUNA blood sugar. To ensure precise results to each glycemic values test, follow the recommended procedures to obtain a blood sample:
- clean the site chosen for testing with soapy hot water, then rinse and dry thoroughly;
- if you use a tampon with alcohol, make sure that the washing site is completely dry before proceeding;
- drill the chosen site to get the blood out. After drying the first drop of blood, it is possible to gently massage or fry the area to take the necessary amount of blood. Do not press excessively on the puncture site;
- to get a drop of blood large enough, you can adjust the drilling device deeper.

Test execution mode
1. Remove a strip from the bottle and stop it immediately.
2. Securely insert the strip into the meter that will turn on automatically.
3. Check that the "GLUC" test mode symbol is on the top of the meter's LCD screen. If the test mode is not "GLUC", enter a new strip.
4. Use the drilling device to get a blood drop of correct size. Refer to the user manual or to the finger tip drilling instructions.
5. The meter shows the blood drop symbol on the screen, gently touch the blood sample with the tip of the strip. The blood sample will be sucked into the reaction area of the strip. When the amount of blood is sufficient, the countdown will begin after an acoustic signal issued by the meter.
6. Read the test result at the end of the countdown. The result will be stored in the memory of the meter.
7. Remove the strip from the meter that will turn off automatically. The meter will automatically turn off even after 3 minutes of inactivity.

Results
Wellion LUNA series meters display the results of the 20 mg/dL blood sugar test (1,1 mmol/l) to 600 mg/dL (33,3 mmol/l). Glycemic values for people without diabetes:
- in general, the fast glucose rate 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, the normal glycemic value must be between 120-160 mg/dL (6,7-8,9 mmol/l) respectively;
- between 2 and 4 in the morning blood sugar must be more than 70 mg/dL (3,9 mmol/l).

Unforeseen or uncertain results
Glycemic values too low or too high could be symptomatic of even severe diseases. If the glycemic value is unusually high or low or does not reflect the subjective state of well-being, repeat the test with a new reactive strip. If the value detected does not conform to its state of well-being or if the result of glycemia is less than 70 mg/dL (3.9 mmol/l) or more than 180 mg/dL (10.0 mmol/l), please contact the health operator and follow the therapeutic suggestions. If the test results are unusual or inconsistent, check the following:
- verify that the reactive strips are not expired;
- verify the performance of the meter and reactive strips by performing a test with a control solution;
- verify that the blood sample fills the reactive strip test zone completely.

Warnings
1. Please contact your doctor or health care professional before making any therapeutic modification based on the results of the test performed with the Wellion LUNA series meter.
2. For the use of the reactive strip for the measurement of the Wellion LUNA blood sugar with the Wellion LUNA meters it is recommended to take the whole blood from the tip of the finger.

Precautions
1. This system is used only for in-vitro diagnostics.
2. The reactive strips of other brands are not approved for use with the gauges of the Wellion LUNA series; the use of reactive strips other than the reactive strip for the measurement of the Wellion LUNA glycemia can generate incorrect results.
3. Potential biological risk. Healthcare professionals and others who use this system on multiple people 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 run the test until the test result with the control solution falls into the control range. The system does not work properly if you continue to get test results with the control solution not falling within the range.

Limitation
Observe the following limitations to obtain precise test results for blood sugar with Wellion LUNA series meters and strip:
- only for in-vitro diagnostics (only for external use);
- do not expose reactive strips to high humidity or direct sunlight. Do not freeze strips;
- the reactive strip for the measurement of Wellion blood sugar is only disposable, do not reuse it;
- manipulate the strip with clean and dry hands; clean and dry thoroughly the drilling site for the test;
- do not test with a mobile phone in use nearby; avoid interference of electronic signals. ;
- high altitude effect: the reactive strips for the measurement of Wellion glycemia can be used at an altitude of up to 3048 m without effects on the test results. ;
- the haematocrite range (Hct) between 25-60% is acceptable. The Hct below 25% can generate high results. The Hct greater than 60% can generate reduced glycemic values than the reference for the whole blood;
- the reactive strips for the measurement of Wellion LUNA glycemia have not been validated for testing on neonatal blood samples. Do not use reactive strips for testing on newborns;
- reactive strips react only with D-glucose and not with other sugars that may be present in the blood.

Components
Oxidized glucose: >5 units (Aspergillus Niger).
Other components (buffer, mediator, surfactant, stabilizer, etc.): >0.2 mg Conservation
Store at room temperature between 4-30 °C (39-86 °F). Do not expose directly to sunlight and heat. After picking a strip, close the bottle immediately. Use the strip immediately after removing it from the bottle. Store the reactive strips always in the original bottle. Do not bend, cut or bend the strips. Manipulate, remove, touch and insert the strip gently with clean and dry hands.

Cod. WELL612