Description
In vitro diagnostic medical device.
Sensors for the quantitative determination of glucose levels in fresh capillary whole blood; they are to be used exclusively with the GlucoMen areo 2K instrument.
The sensors have been designed for monitoring and self-testing of blood glucose levels in people with diabetes mellitus; they can also be used in hospitals by medical and healthcare personnel.
Not intended for use in the diagnosis or screening of diabetes or for use in neonates.
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
Enzymatic composition (per cm2) of a test strip for blood glucose measurement	- glucose oxidase (from Aspergillus niger), 3.5% - mediator: hexacyanoferrate (III) ion, 17.5% - non-reactive substances, 79%
Unit of measure
Glucose	mg/dL (non-modifiable)
Measurement 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 hematocrit (10-70%)
Correlation	plasma equivalent
Sample	fresh capillary whole blood
Sensor coding	auto-coding
Hygiene	automatic test strip ejection using a dedicated ejection button
Sampling	automatic aspiration of blood sample by capillarity
Use of alternative sites (AST)	allowed (palm of hand and forearm)
Operating environment	temperature range: 5-45°C humidity: 20%-90% (non-condensing)

Instructions for use
1. Insert a new GlucoMen areo Sensor (white color) into the sensor insertion slot. The drop symbol will start flashing on the display and the glucose symbol Glu will appear in the bottom left. If nothing appears on the display, remove the sensor, reinsert it into the slot and wait for the drop symbol to start flashing.
For information on how to use the lancing device, read its instructions for use.
2. Hold the tip of the sensor in contact with the blood drop until the control window is filled. At this point, an audible signal will sound (if enabled) and the display will show a countdown.
3. Read the test results. An audible 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 reach and sight of children. Small parts can pose a choking hazard.
Handle the bottle and sensors with clean, dry hands.
Dispose of the bottle and used sensors in accordance with local regulations.
Handling blood can be dangerous: exercise extreme caution when handling blood, sensors, lancets 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.
Store all unused sensors in their original bottle and after removing one, close the cap tightly to preserve their quality. Do not transfer sensors to other containers.
Do not use sensors beyond the expiration date.
Do not use sensors more than 12 months after the first opening of their bottle. It is recommended to write the disposal date on the label (date of first opening + 12 months).
Strips in unopened packaging have a validity of 24 months from the manufacturing date.

Format
Pack of 10 sensors.

Code 48526