In vitro diagnostic medical device.
System for self-monitoring of blood glucose and ketonemia.
System indicated for the quantitative determination of the concentration of glucose and beta-hydroxybutyrate (beta-ketone) in fresh capillary whole blood.
Conceived for the self-control of diabetes mellitus, for the monitoring and control of glycemia and ketonemia, it can also be used in hospital by medical-health personnel.
It is not intended for the diagnosis or screening of diabetes and ketonemia, or for use in infants.
Do not change your therapy based on the results of tests carried out with the instrument without first consulting your doctor or medical staff.

General features
specificity for beta-D-glucose in the blood 0.1-8.0 mmol / L 10-70% (compensated hematocrit) 20-60% (compensated hematocrit) USB connection cable available free of charge at the toll-free number 800869110 of the A. Menarini Diagnostics Customer Service temperature: 10-40 ° C
relative humidity: <85% 85.5mm (W) x 56mm (D) x 18.2mm (H) 46 g (without batteries)

Reactive strip	exclusively GlucoMen areo Sensor and GlucoMen areoBeta-Ketone Sensor
Blood glucose measurement
Enzymatic composition (per cm 2 ) 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%
Measurement of ketoneemia	beta-hydroxybutyrate (beta-ketone) in the blood
Enzymatic composition (per cm 2 of a reactive strip for the measurement of ketonemia	-D-3-hydroxybutyrate dehydrogenase ( Pseudomonas sp. ) 1.5% w / w - coenzyme (NAD +), 0.7% w / w - redox mediator: 1,10-phenanthroline-5,6-dione, 20,0% w / w - non reactive substances: 77.8% w / w
Unit of measure
Glucose	mg / dL (non-modifiable)
Beta-ketone	mmol / L (unmodifiable)
Measurement range
Glucose	20-600 mg / dL
Beta-ketone
Response time
Glucose	5 seconds
Beta-ketone	8 seconds
Sample volume
Glucose	0.5 microL
Beta-ketone	0.8 microL
Range of acceptability of hematocrit
Glucose
Beta-ketone
Glucose test calibration	the results are equivalent to the plasma glucose concentration (capillary plasma). The GlucoMen areo 2K System is calibrated to capillary plasma values determined with a Yellow Springs 2300 (YSI) analyzer. The YSI analyzer is calibrated (as a secondary reference measurement procedure) using a set of YSI standards (primary calibrators) acquired directly from NIST ( National Institute of Standards and Technology, USA).
Ketonemia test calibration	The GlucoMen areo 2K system was calibrated to the plasma reference values determined with a Stanbio Beta-Hydroxybutyrate LiquiColor procedure, Procedure No. 2440 (Stanbio Laboratory, 1261 North Main Street, Boerne, Texas 78006). The analyzer using the Stanbio kit (secondary reference measurement procedure) was calibrated with a series of standards containing beta-hydroxybutyrate (primary calibrators) prepared by gravimetric method at the Stanbio Laboratory.
Hygiene	automatic ejection of the reactive strip by means of a dedicated eject button
Sampling	automatic aspiration of the blood sample by capillarity
BVC	control volume of blood aspirated. The blood is self-aspirated by capillarity from the sensor and as soon as it reaches the detection electrode, the measurement starts automatically. The reaction does not occur if the blood volume of the sample does not reach the minimum required quantity (if the volume is insufficient, the error Er 3 is displayed)
Use of alternative sites (AST)	allowed (palm and forearm)
Memory capacity	730 blood glucose results and 100 beta-ketone results with markers, dates and times. When memory is full, the new result will replace the older one
External connection	via dedicated cable, NFC or Bluetooth device
Output specifications
Battery life	900 tests minimum, or about 1 year (2-3 tests per day)
Operating environment
Glucose	temperature: 5-45 ° C relative humidity: 20% -90% (non-condensing)
Beta-ketone
Dimensions
Weight

How to use
Blood glucose test procedure
1. Insert a new GlucoMen areo Sensor (white color) into the sensor insertion opening. The drop symbol will start flashing on the display and the glucose "Glu" 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, please read its instructions for use.
2. Keep the tip of the sensor in contact with the drop of blood until the sight glass is full. At that point you will hear an acoustic signal (if enabled) and the display will show a countdown.
3. Read the test results. An audible signal will announce that the test result will appear on the screen with the glucose symbol "Glu".
4. To remove the sensor, press the eject button. The instrument will shut down.

Ketonemia test procedure
1. Introduce a new GlucoMen areo Beta-Ketone Sensor (light purple color) into the sensor insertion opening. The drop symbol will start flashing on the display and the ketone symbol "Keth" 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.
2. Keep the tip of the sensor in contact with the drop of blood until the sight glass is full. You will hear a beep (if enabled) and the display will show a countdown.
3. Read the test results. An acoustic signal will announce that the test result will appear on the screen with the ketone symbol "Keth". The symbol will flash until the instrument is switched off.
4. To remove the sensor, press the eject button. The instrument will shut down.
Do not use the GlucoMen areo Beta-Ketone Sensor to test samples taken from alternative sites: use only fresh capillary blood taken from the fingertips.

Warnings
Keep the meter, sensors, and other components out of the reach and sight of children. Small parts can be 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
Instrument storage conditions:
- temperature: -20-50 ° C;
- relative humidity: 20-90%.
Do not store or use the instrument in environments where:
- the temperature could fluctuate abruptly;
- the humidity is high and causes condensation (bathroom, laundry, kitchen, etc.);
- in the presence of a strong electromagnetic field (near a microwave oven, a mobile phone, etc.).

Format
Pack of 1 piece.

Code 49195