Description Medical Diagnostic Device
in vitro.
System for self-control of blood sugar and ketonemia.
System indicated for the quantitative determination of glucose concentration and beta-hydroxybutyrate (beta-ketone) in fresh capillary whole blood.
Conceived for the self-control of diabetes mellitus, for the monitoring and control of blood sugar and ketonemia, it can also be used in a hospital setting by medical and health personnel.
It is not intended for the diagnosis or screening of diabetes and ketonemia, or for use in infants.
Do not modify your therapy on the basis of the results of the tests carried out with the instrument without having first consulted your doctor or medical-health personnel.
General characteristics
Reactive Strip |
Exclusively GlucoMen areo Sensor and GlucoMen areo Beta-Ketone Sensor |
Measurement of blood sugar |
Specificity for beta-D-glucose in the blood |
Enzymatic composition (per cm2) Of a test strip for blood sugar measurement |
-Glucose oxidase (from Black Aspergill), 3,5% -Mediator: hexacianoferrate (III) ion, 17.5% -Non-reactive substances, 79% |
Measurement of ketonemia |
Beta-hydroxybutyrate (beta-ketone) in the blood |
Enzymatic composition (per cm2 Of a test strip for the measurement of ketonemia |
-D-3-idrosibutirrat deigrogenasi (Pseudomonas sp.) 1.5% w/w -Coenzima (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 measurement |
Glucosio |
Mg/dL (not modifiable) |
Beta-ketone |
Mmol/L (non-modifiable) |
Measurement Range |
Glucosio |
20-600 mg/dL |
Beta-ketone |
0,1-8,0 mmol/L |
Response Time |
Glucosio |
5 seconds |
Beta-ketone |
8 seconds |
Sample volume |
Glucosio |
0,5 microL |
Beta-ketone |
0,8 microL |
Hematocrit Acceptability Range |
Glucosio |
10-70% (plywood hematocrit) |
Beta-ketone |
20-60% (plywood hematocrit) |
Glucose test calibration |
Results are equivalent to the concentration of glucose in plasma (capillary plasma). The GlucoMen areo 2K system is calibrated to the capillary plasma values determined with a Yellow Springs 2300 (YSI) analyzer. The YSI analyzer is calibrated (as a reference secondary measurement procedure) using a series 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 plasma reference values determined by 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) has been calibrated with a series of standards containing beta-hydroxybutyrate (primary calibrators) prepared by the gravimetric method at the Stanbio Laboratory. |
Hygienicity |
Automatic ejection of the test strip by means of a dedicated ejection key |
Campioning |
Automatic blood sample suction for capillarity |
BVC |
Control volume of aspirated blood. The blood is self-aspirated by capillarity by 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 required minimum quantity (error Er 3 is displayed if the volume is insufficient) |
Use of alternative sites (AST) |
Allowed (palm and forearm) |
Memory Capacity |
730 glycemic results and 100 Beta-ketone results with markers, dates and times. When the memory is full, the new result will replace the older one |
External connection |
Via dedicated cable, NFC or Bluetooth device |
Output Specifications |
USB connection cable that can be requested free of charge to the toll-free number 800 869110 of Customer Service A. Menarini Diagnostics |
Battery life |
900 minimum test, or about 1 year (2-3 tests per day) |
Operating environment |
Glucosio |
Temperature: 5-45 °C Relative humidity: 20%-90% (without condensation) |
Beta-ketone |
Temperature: 10-40 °C Relative humidity: <85% |
Dimensions |
85,5 mm (L) x 56 mm (P) x 18,2 mm (A) |
Weight |
46g (without batteries) |
How to use Blood sugar test procedure 1. Introduce a new GlucoMen areo Sensor sensor (white color) in the opening for the insertion of sensors. The drop symbol will start flashing on the display and the glucose symbol "Glu" will appear at the bottom left. If nothing appears on the display, remove the sensor, insert it back into the opening and wait until the drop symbol starts flashing.
For information on how to use the lancing pen, read the relevant instructions for use.
2. Keep the end of the sensor in contact with the blood drop until the control visor is filled. At that point you will hear a beep (if enabled) and the display will display a countdown.
3. Read the test results. A beep will announce the appearance on the screen of the test result with the glucose symbol "Glu".
4. To remove the sensor, press the ejection button. The instrument will shut down.
Ketonemia test procedure 1. Introduce a new GlucoMen areo Beta-Ketone Sensor (light purple color) sensor in the aperture for inserting the sensors. 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 end of the sensor in contact with the blood drop until the control visor is filled. You will hear a beep (if enabled) and the display will display a countdown.
3. Read the test results. A beep will announce the appearance on the screen of the test result with the ketone symbol "Keth". The symbol will flash until the instrument is switched off.
4. To remove the sensor, press the ejection button. The instrument will shut down.
Do not use the GlucoMen areo Beta-Ketone Sensor sensors to test samples taken from alternative sites: use only fresh capillary blood taken from the fingertips.
Warnings Keep the instrument, sensors and other components out of reach and sight of children. Small parts can be a choking hazard.
Handle the bottle and sensors with clean and dry hands.
Dispose of the bottle and sensors used in accordance with local regulations.
Handling blood can be dangerous: take extreme care by handling blood, sensors, lancets and instrument.
storage Instrument storage conditions:
-Temperature: -20-50 °C;
-Relative humidity: 20-90%.
Do not store or use the instrument in environments where:
-The temperature may fluctuate abruptly;
-The humidity is high and causes condensation (bathroom, laundry, kitchen, etc.);
-You are in the presence of a strong electromagnetic field (near a microwave oven, a mobile phone, etc.).
Format Pack of 1 piece.
Cod. 49195