Description
In vitro diagnostic medical device.
Sensors for the quantitative determination of glucose levels in fresh capillary whole blood; to be used exclusively with the GlucoMen areo 2K instrument.
The sensors are designed for monitoring and self-monitoring blood glucose levels in people with diabetes mellitus; they can also be used in hospital settings by healthcare professionals.
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 glucose measurement	specificity for beta-D-glucose in blood
Enzyme composition (per cm2 ) of a blood glucose test strip	- glucose oxidase (from Aspergillus niger ), 3.5% - mediator: hexacyanoferrate (III) ion, 17.5% - non-reactive substances, 79%
Unit of measurement
Glucose	mg/dL (not modifiable)
Measuring range
Glucose	20-600 mg/dL
Response time
Glucose	5 seconds
Sample volume
Glucose	0.5 microL
Acceptable hematocrit range
Glucose	automatically corrects the measurement based on the hematocrit (10-70%)
Correlation	plasma equivalent
Sample	fresh capillary whole blood
Sensor coding	self-coding
Hygiene	automatic ejection of the test strip via dedicated ejection button
Sampling	automatic blood sample aspiration by capillary action
Use of alternative sites (AST)	allowed (palm and forearm)
Operating environment	Temperature range: 5-45°C Humidity: 20%-90% (non-condensing)

How to use
1. Insert a new GlucoMen areo Sensor (white) into the test strip port. The drop symbol will start flashing on the display and the glucose symbol "Glu" will appear in the lower left corner. If nothing appears on the display, remove the sensor, reinsert it into the port, and wait for the drop symbol to start flashing.
For information on how to use the lancing device, read the instructions for use.
2. Hold the tip of the sensor in contact with the blood drop until the control window fills. You will then hear a beep (if enabled) and the display will show a countdown.
3. Read the test results. A beep 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 according to local regulations.
Handling blood can be dangerous: use extreme caution when handling blood, sensors, lancets, and the meter.

Conservation
Store the sensor vial in a dry place at 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 the sensors for more than 12 months after first opening the bottle. It is recommended to write the disposal date on the label (first opening date + 12 months).
Unopened strips have a shelf life of 24 months from the date of manufacture.

Format
Pack of 50 sensors.

Code 49198