Description
In vitro diagnostic medical device.
Sensors for the quantitative determination of glucose levels in fresh capillary whole blood; for exclusive use with the GlucoMen areo 2K device.
The sensors are designed for monitoring and self-monitoring 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 personnel.

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 measurement
Glucose	mg/dL (not 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 blood sample aspiration by capillarity
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 color) into the sensor insertion slot. 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, reinsert it into the slot and wait for the drop symbol to start flashing.
For information on how to use the lancing device, read the relevant instructions for use.
2. Hold the end of the sensor in contact with the blood drop until the control window is filled. A beep will then sound (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 Glu glucose symbol.
4. To remove the sensor, press the eject button. The device will turn off.

Warnings
Keep the device, sensors and other components out of reach and sight of children. Small parts can be a choking hazard.
Handle the vial and sensors with clean, dry hands.
Dispose of the vial and used sensors in accordance with local regulations.
Handling blood can be dangerous: exercise extreme caution when handling blood, sensors, lancets and the device.

Storage
Store the sensor vial 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 vial 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 vial. It is recommended to write the disposal date (first opening date + 12 months) on the label.
The sealed strips have a shelf life of 24 months from the date of manufacture.

Format
Pack of 25 sensors.

Code 48528