GLUCOMEN AREO 2K GLUCOMETER FOR SELF-MEASUREMENT OF BLOOD SUGAR FROM CAPILLARY WHOLE BLOOD DIMENSIONS 85.5X56X18.2 MM WEIGHT 46 G GLUCOMEN

Description
In vitro diagnostic medical device.
System for self-monitoring of blood glucose and ketonemia.
System indicated for the quantitative determination of glucose and beta-hydroxybutyrate (beta-ketone) concentration in fresh capillary whole blood.
Designed for self-monitoring of diabetes mellitus, for monitoring and controlling blood glucose and ketonemia, it can also be used in hospital settings by medical personnel.
It is not intended for the diagnosis or screening of diabetes and ketonemia, nor for use on neonates.
Do not change your therapy based on the results of tests performed with the instrument without first consulting your doctor or healthcare professional.

General characteristics

Test strip	exclusively GlucoMen areo Sensor and GlucoMen areo Beta-Ketone Sensor
Blood sugar measurement	specificity for beta-D-glucose in blood
Enzyme composition (per cm2 ) of a test strip for measuring blood glucose	- glucose oxidase (from Aspergillus niger ), 3.5% - mediator: hexacyanoferrate (III) ion, 17.5% - non-reactive substances, 79%
Measurement of blood ketonemia	beta-hydroxybutyrate (beta-ketone) in the blood
Enzyme composition (per cm2 of a test strip for measuring 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 measurement
Glucose	mg/dL (not modifiable)
Beta-ketone	mmol/L (not modifiable)
Measuring range
Glucose	20-600 mg/dL
Beta-ketone	0.1-8.0 mmol/L
Response time
Glucose	5 seconds
Beta-ketone	8 seconds
Sample volume
Glucose	0.5 microL
Beta-ketone	0.8 microL
Acceptable Hematocrit Range
Glucose	10-70% (compensated hematocrit)
Beta-ketone	20-60% (compensated hematocrit)
Glucose Test Calibration	The results are equivalent to the glucose concentration in plasma (capillary plasma). The GlucoMen areo 2K system is calibrated to capillary plasma values ​​determined with a Yellow Springs 2300 analyzer (YSI). 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).
Ketone test calibration	The GlucoMen areo 2K system has been calibrated to 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) has been calibrated with a series of beta-hydroxybutyrate-containing standards (primary calibrators) prepared gravimetrically at Stanbio Laboratory.
Hygiene	Automatic ejection of the test strip via dedicated ejection button
Sampling	automatic blood sample aspiration by capillary action
BVC	control of aspirated blood volume. The blood is self-aspirated by capillary action 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 glucose results and 100 Beta-ketone results with markers, dates and times. When the memory is full, the new result will replace the oldest one
External connection	via dedicated cable, NFC or Bluetooth device
Output Specifications	USB connection cable available free of charge by calling the A. Menarini Diagnostics Customer Service toll-free number 800 869110
Battery life	900 tests minimum, or approximately 1 year (2-3 tests per day)
Operating environment
Glucose	temperature: 5-45°C Relative humidity: 20%-90% (non-condensing)
Beta-ketone	temperature: 10-40°C relative humidity: <85%
Dimensions	85.5mm (W) x 56mm (D) x 18.2mm (H)
Weight	46 g (without batteries)

How to use
Blood glucose test procedure
1. Insert a new GlucoMen areo Sensor (white) into the sensor port. 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 port and wait for the drop symbol to start flashing.
For information on how to use the lancing device, read the instructions for use provided with it.
2. Hold the tip of the sensor in contact with the drop of blood until the control window fills. You will then hear a beep (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 instrument will turn off.

Ketonemia test procedure
1. Insert a new GlucoMen areo Beta-Ketone Sensor (light purple) into the sensor port. The drop symbol will start flashing on the display and the ketone symbol "Keth" will appear in the bottom left. If nothing appears on the display, remove the sensor, reinsert it into the port and wait for the drop symbol to start flashing.
2. Hold the tip of the sensor in contact with the drop of blood until the control window fills. You will hear a beep (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 ketone symbol " Keth". The symbol will flash until the meter turns off.
4. To remove the sensor, press the eject button. The instrument will turn off.
Do not use the GlucoMen areo Beta-Ketone Sensor to test samples from alternative sites: use only fresh capillary blood from the fingertip.

Warnings
Keep the instrument, sensors and other components out of the reach and sight of children. Small parts may pose a choking hazard.
Handle the bottle and sensors with clean, dry hands.
Dispose of the used bottle and sensors according to local regulations.
Handling blood can be dangerous: use extreme caution when handling blood, sensors, lancets, and the meter.

Conservation
Storage conditions of the instrument:
- temperature: -20-50°C;
- relative humidity: 20-90%.
Do not store or use the instrument in environments where:
- the temperature may fluctuate rapidly;
- humidity is high and causes condensation (bathroom, laundry room, kitchen, etc.);
- there is a strong electromagnetic field (near a microwave oven, a cell phone, etc.).

Format
Pack of 1 piece.

Code 49195