Descriptive sheet
LINEAD EVO
Test strips
Bioseven LineaD Evo strips can only be used in combination with the LineaD Evo glucometer.
The LineaD Evo blood glucose monitoring system is used in in vitro diagnostics (extracorporeal application). It is indicated for monitoring blood glucose levels in capillary whole blood, collected from the finger, palm, or forearm. The system guarantees capillary blood results comparable to those determined with laboratory instruments.
Test procedure
Preparing the lancing device.
1) Grasp the depth-adjustable cap with one hand and the main body with the other. Bend the cap downward. As the cap separates from the main body, pull the two in opposite directions.
2) Remove the plug with adjustable depth.
3) Insert a new disposable lancet and secure it in the holder.
4) Unscrew and set aside the protective cap of the disposable lancet.
5) Replace the depth-adjustable cap.
6) Select the penetration depth by rotating the top of the adjustable depth cap until the adjustable depth matches the window. The settings depend on your skin type.
7) Hold the device with one hand and the piston with the other. The device is ready. When released, the piston will return to its original position.
Test preparation
1) Wash your hands with soap and dry them thoroughly.
2) Take a strip from the bottle and close it immediately.
3) Insert the test strip into the appropriate slot on the meter with the indicator facing upwards.
4) When the drop symbol flashes, apply the blood sample within 2 minutes.
5) Place the lancing device on your fingertip and release the mechanism as instructed. You can also draw blood from the palm or forearm.
Test result
- Test results are displayed on the meter in mg/dL.
- If the result is unusual (too high or too low) or inconsistent, repeat the test with a new test strip. You can also check the system using Bioseven LineaD control solution. If the results are still too high or too low, consult your doctor immediately.
- If you experience symptoms that do not match your blood glucose test results and you are sure you have followed these instructions for use, contact your doctor immediately or follow his or her treatment instructions.
- The LineaD Evo meter displays results between 10 and 600 mg/dL or 0.6 and 33.3 mmol/L. If your test result is less than 10 mg/dL or 0.6 mmol/L, Lo will appear on the display. Repeat the test with a new test strip. If the result is still Lo, consult your doctor or proceed as directed.
- If your test result is higher than 600 mg/dL or 33.3 mmol/L, Hi will appear on the screen. Repeat the test with a new test strip. If your result is still Hi, consult your doctor or follow your doctor's instructions.
Precautionary measures
- Check the expiration date on the test strips before each test. Never use expired strips.
- Close the package immediately and completely after removing a test strip.
- Do not perform any system checks with expired control solution.
- Do not bend or twist the test strips. Damaged strips may distort the results.
- Never use test strips and lancets more than once.
- Wait at least 30 minutes before performing a test if the device has been brought to the measurement site from an environment with a large temperature difference.
Warning
Keep the strips and the lid out of the reach of children. Swallowing them could cause choking. If a strip or the lid is swallowed, consult a doctor immediately.
Conservation and treatment
- Store the strips in the tightly closed original bottle at temperatures between 4°C and 30°C (39 - 86°F) and relative humidity less than 90%.
- Do not freeze.
- Recap the bottle immediately after removing the test strips. Do not leave the bottle open. If exposed to air for too long, the strips will absorb moisture, causing false results.
- When opening a new bottle of test strips, write the opening date on the label. Use the test strips within 3 months of first opening or by the expiration date shown on the label (whichever comes first).
Reagents
Each LineaD Evo blood glucose test strip contains the following reagents:
Glucose oxidase (Aspergillus niger) (GOD): 14.8%
Potassium ferricyanide: 39.5%
Non-reactive components: 45.7%.
Format
Pack of 25 and 50 strips.
Cod. BIO011 / BIO012