A. Menarini Diagnostics GlucoMen Areo Sensor Strips For Measurement Of Blood Glucose Description In vitro diagnostic medical device. Sensors for the quantitative determination of fresh interapapillar blood glucose level; they are to be used exclusively with the GlucoMen areo2K instrument. Sensors have been designed for monitoring and self-monitoring of blood glucose levels in people with diabetes mellitus; they can also be used in hospitals by medical personnel. It is not intended for use in the diagnosis or screening of diabetes or use in newborns. Do not modify your treatment based on test results without first consulting your doctor or health care professional. General characteristics 0.5 microL Blood glucose measurement specificity for beta-D-glucose in the blood Enzyme composition (per cm 2 ) of a blood glucose test strip - glucose oxidase (from Aspergillus niger ), 3.5% - mediator: exacyanoferrate ion (III), 17.5% - non-reactive substances, 79% Unit of measure Glucose mg / dL (unmodifiable) Measurement range Glucose 20-600 mg / dL Response time Glucose 5 seconds Sample volume Glucose Acceptance range of the hematocrit Glucose performs automatic correction of the measurement according to the hematocrit (10-70%) Correlation equivalent plasma Sample fresh capillary whole blood Sensor coding autocode hygiene automatic ejection of the reactive strip through a dedicated ejection button Sampling automatic aspiration of the sample disrupts by capillarity Use of alternative sites (AST) allowed (palm of hand and forearm) Operating environment temperature range: 5-45 ? C humidity: 20% -90% (without condensation) How to use 1. Introduce a new GlucoMen areo Sensor (white color) into the opening for sensor insertion. The drop symbol will start to flash on the display and the \"Glu\" glucose symbol will appear at the bottom left. If nothing appears on the display, remove the sensor, insert it back into the opening and wait for the drop symbol to start flashing. For information on how to use the lancing device, read the appropriate instructions for use. 2. Hold the end of the sensor in contact with the drop of blood until the control cover is filled. At that point you will hear an acoustic signal (if enabled) and the display will show a countdown. 3. Read the test results. An acoustic signal will announce the appearance of the test result with the \"Glu\" glucose symbol on the screen. 4. To remove the sensor press the eject button. The tool will remotely. Warnings Keep the instrument, sensors and other components away from the reach and sight of children. Small parts can be a choking hazard. Handle the bottle and the sensors with clean and dry hands. Dispose of the used bottle and sensors in accordance with local regulations. Handling blood can be dangerous: take extreme care by handling the blood, the sensors, the hands and the instrument. storage Store the sensor bottle in a dry place, at a temperature of 4-30 ? C. Do not freeze. Avoid heat and direct sunlight. Keep all unused sensors in the original bottle and after having taken one, close the cap firmly to preserve the quality. Do not transfer the sensors to other containers. Do not use the sensors beyond the expiration date. Do not use the sensors more than 12 months after first opening their bottle. The date of disposal (first opening date + 12 months) is recommended on the label. The strips in a closed package are valid for 24 months from the date of manufacture. Format Pack of 50 sensors. Cod. 49198