Description
Blood glucose sensors.
Use GLUCOFIX TECH Sensors exclusively with GLUCOFIX TECH line of instruments for the quantitative determination of glucose levels in fresh capillary whole blood. The GLUCOFIX TECH line includes the following instruments: GLUC0FIX TECH for the determination of blood glucose, GLUCOFIX TECH 2K and GLUCOFIX TECH GK for the determination of glucose and p-hydroxybutyrate (beta-ketone).
GLUCOFIX TECH Sensors are an in vitro diagnostic medical device.
The sensors are intended for monitoring and self-monitoring blood glucose levels in people with diabetes mellitus; they can also be used in hospital settings by healthcare professionals. They are not intended for use in the diagnosis or screening of diabetes or in newborns. Do not change your treatment based on test results without first consulting your doctor or healthcare professional.
The glucose in the blood sample binds to the reagents on the sensor, and this reaction produces a small electrical current whose intensity is proportional to the glucose concentration in the blood. The device measures this current and calculates the blood glucose values.

How to use
To obtain accurate test results, allow the sensors and meter to adjust to their surroundings for at least 30 minutes before checking your blood glucose. Operating conditions are: temperature 5-45°C (41-113°F); relative humidity 20-90%.
1. Remove 1 sensor from the bottle with clean, dry hands.
- Sensors are for single use only. Do not use sensors if they are wet, damaged, or stored in a damaged bottle.
- Close the bottle cap tightly immediately after removing the sensor.
- Use the sensor immediately.
2. Insert a new sensor into the sensor opening on the instrument. The drop symbol will start flashing on the display.
3. Collect a blood sample using a lancing device and a new lancet, following the instructions for use.
4. Bring the drop of blood to the end of the sensor until the control window is full.
- Do not test for blood that drips or spreads from the puncture site.
- Do not smear blood on the sensor.
- Do not press the sensor forcefully on the puncture site.
- Do not touch the sensor when the meter has started counting down.
5. The test result will appear on the screen as soon as the test is completed.
6. Press the eject button to remove the sensor.
- Once used for blood glucose monitoring, sensors and lancets become biohazardous waste and must be disposed of in accordance with local biohazardous waste regulations.
- If the test results are not consistent with your perceived health status:
• Make sure you performed the test correctly, as explained in the user manual. Then, perform a control test to verify that the system is working properly. If blood from the palm or forearm was used, repeat the test using a blood sample from the fingertip (do not use an alternate sampling site). If the test result is still not consistent with your perceived health status, consult your doctor or healthcare professional.

Warnings
- Keep the instrument, sensors, and other components out of the reach and sight of children. Small parts may pose a choking hazard.
- Handle the bottle and sensors with clean, dry hands.
- Dispose of the used bottle and sensors in accordance with local regulations.
Handling blood can be dangerous. You or others could become infected with pathogenic microorganisms due to incorrect or imprecise procedures. Use extreme caution when handling blood, sensors, lancets, and the device.

Limitations
- Do not use plasma or serum samples.
- Do not analyze venous or arterial blood samples.
- Do not test samples taken from newborns.
- Test results are not affected by altitude up to 3150 m above sea level.
- Permissible hematocrit range: 10-70%.
- cyclodextrin and its metabolites (maltose, maltotriose and maltotetraose) do not significantly influence the test results.
- Dopamine (>0.1 mg/dl), L-Dopa (>3 mg/dl) and acetaminophen (>15 mg/dl) may influence the results.
- The system results are not affected by a sample oxygen partial pressure (p02) between 52-115 mmHg (6.9-15.3 kPa).
Below 52 mmHg (6.9 kPa) the system will overestimate glucose levels, while above 1115 mmHg (15.3 kPa) the system will underestimate the measurement.

Conservation
Store the sensor vial in a dry place (20-90% RH) at a temperature of 4-30°C (39.2-86°F). Do not freeze. Avoid heat and direct sunlight.
Store all unused sensors in the original bottle, and after removing one, close the cap tightly to preserve its quality. Do not transfer sensors to other containers.
Do not use sensors beyond their expiration date.
Shelf life after opening: 12 months.

Format
25 strips.

Cod. 48585