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wellion MOON 25 GLU Description Test strips for measuring blood glucose. The Wellion LUNA blood glucose test strip is intended for measuring blood glucose values in whole blood for self-monitoring with Wellion LUNA series meters at home and at clinical sites by healthcare professionals (in vitro diagnostics). The Wellion LUNA blood glucose test strip uses electrochemical biosensor technology. A whole blood sample is automatically drawn from a reaction zone on the strip via a capillary tube, resulting in a stable sample volume. When the glucose in the whole blood sample reacts with the reagent on the electrodes, the Wellion LUNA series meters detect a current when a fixed potential is applied between the electrodes. This current is then converted into a blood glucose reading. How to use Procedures for sampling A fresh capillary blood sample is required for use with Wellion LUNA blood glucose test strips. To ensure accurate results with every blood glucose test, follow these 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, make sure the site to be pierced is completely dry before proceeding; - puncture the chosen site to allow the blood to flow. After wiping away the first drop of blood, you can gently massage or rub the area to draw the necessary amount of blood. Do not apply excessive pressure to the puncture site; - to obtain a sufficiently large drop of blood, you can adjust the piercing device deeper. How to perform the test 1. Remove a strip from the bottle and cap it immediately. 2. Insert the strip firmly into the meter which will turn on automatically. 3. Check that the GLUC test mode symbol is at the top of the meters LCD screen. If the test mode is not GLUC, insert a new strip. 4. Use the lancing device to obtain the correct size drop of blood. Refer to the user manual or fingertip lancing instructions. 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 reaction area of the strip. When the amount of blood is sufficient, the countdown will begin after the meter beeps. 6. Read the test result after the countdown. The result will be stored in the meters 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 The 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: - in general, 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, the normal blood glucose value should be between 120-160 mg/dL (6.7-8.9 mmol/l) respectively; - between 2 and 4 in the morning your blood glucose level must be above 70 mg/dL (3.9 mmol/l). Unexpected or uncertain results Blood glucose levels that are too low or too high may be symptomatic of a serious illness. If your blood glucose level is unusually high or low or does not reflect your current state of well-being, repeat the test with a new test strip. If your blood glucose reading is not consistent with your current state of well-being, or if your blood glucose result is less than 70 mg/dL (3.9 mmol/L) or greater than 180 mg/dL (10.0 mmol/L), contact your healthcare provider and follow their treatment recommendations. If your test results are unusual or inconsistent, check the following: - check that the test strips have not expired; - check the performance of the meter and test strips by performing a test with a control solution; - make sure the blood sample completely fills the test area of the test strip. Warnings 1. Consult your doctor or healthcare provider before making any changes to your treatment based on the results of testing with the Wellion LUNA series meter. 2. When using the Wellion LUNA blood glucose test strip with Wellion LUNA meters, it is recommended to take whole blood from your fingertip. Precautions 1. This system is to be used for in vitro diagnostics only. 2. Test strips from other brands are not approved for use with the Wellion LUNA series meters; using test strips other than the Wellion LUNA blood glucose test strip may result in incorrect results. 3. Potential Biohazard. Healthcare workers and others using this system on multiple people should 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 your control solution test result is within the control range. The system will not function properly if you continue to get out-of-range control solution test results. Limitations Please observe the following limitations to obtain accurate blood glucose test results with the Wellion LUNA series meters and 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; - the Wellion blood glucose test strip is for single use only, do not reuse it; - handle the strip with clean, dry hands; thoroughly clean and dry the test puncture site; - do not perform the test with a cell phone in use nearby; avoid interference from electronic signals. - high altitude effect: Wellion blood glucose test strips can be used at altitudes of up to 3048 m without affecting the test results. - A hematocrit (Hct) range of 25-60% is acceptable. Hct values below 25% may produce elevated results. Hct values above 60% may produce glucose values lower than the whole blood reference; - Wellion LUNA blood glucose test strips have not been validated for testing neonatal blood samples. Do not use the test strips for testing 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 (Aspergillus Niger). Other components (buffer, mediator, surfactant, stabilizer, etc.): >0.2 mg Storage Store at room temperature between 4-30°C (39-86°F). Avoid direct sunlight and heat. After removing a strip, close the bottle immediately. Use the strip immediately after removing it from the bottle. Always store test strips in the original bottle. Do not bend, cut, or curl the strips. Handle, remove, touch, and insert the strip gently with clean, dry hands. Cod. WELL612
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