Description
Diagnostic medical device in vitro.
Sensors for the quantitative determination of the glucose level in fresh capillary whole blood; they are to be used exclusively with the GlucoMen areo 2K instrument.
The sensors were designed for monitoring and self-monitoring of blood glucose levels in people with diabetes mellitus; they can also be used in a hospital environment by medical personnel.
It is not intended for use in the diagnosis or screening of diabetes or for use in newborns.
Do not change your treatment based on test results without first consulting your doctor or healthcare professional.

General characteristics

Blood sugar measurement	specificity for beta-D-glucose in the blood
Enzyme composition (per cm2) of a test strip for measuring blood sugar	- glucose oxidase (from Aspergillus niger), 3.5% - mediator: hexacyanoferrate (III) ion, 17.5% - non-reactive substances, 79%
Unit of measure
Glucose	mg/dL (not editable)
Measuring range
Glucose	20-600 mg/dL
Response time
Glucose	5 seconds
Sample volume
Glucose	0.5 microL
Hematocrit acceptability range
Glucose	automatically corrects the measurement based on the hematocrit (10-70%)
Correlation	equivalent plasma
Sample	fresh capillary whole blood
Sensor coding	autocoding
Hygiene	automatic ejection of the test strip via dedicated ejection button
Sampling	automatic aspiration of the blood sample by capillarity
Use of Alternate Sites (AST)	permitted (palm and forearm)
Operating environment	temperature range: 5-45°C humidity: 20%-90% (without condensation)

Instructions for use
1. Insert a new GlucoMen areo Sensor (white) into the sensor insertion opening. The drop symbol will start flashing 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 its instructions for use.
2. Keep the tip of the sensor in contact with the drop of blood until the control glass fills. 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 on the screen with the glucose symbol "Glu".
4. To remove the sensor, press the eject button. The instrument will turn off.

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: use extreme caution when handling blood, sensors, lancets and the meter.

storage
Store the sensor bottle in a dry place, at a temperature of 4-30°C. 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.
Do not use sensors more than 12 months after first opening their bottle. It is recommended to write the disposal date on the label (first opening date + 12 months).
The strips in unopened packaging are valid for 24 months from the date of manufacture.

Format
Pack of 25 sensors.

Code 48528