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 are designed for monitoring and self-testing of blood glucose levels in people with diabetes mellitus; they can also be used in hospital settings by medical and healthcare professionals.
They are 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 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 via dedicated eject button
Sampling	automatic blood sample aspiration 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 corner. 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, please read its instructions for use.
2. Hold the end of the sensor in contact with the blood drop until the control window fills. 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 glucose symbol Glu.
4. To remove the sensor, press the eject button. The device 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 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 instrument.

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 their original vial and, after removing one, close the cap tightly to preserve their 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.
Sealed strips have a shelf life of 24 months from the manufacturing date.

Format
Pack of 50 sensors.

Cod. 49198