Description
Medical-diagnostic device in vitro.
Sensors for self-control of chetonemia with the GlucoMen areo 2K instrument.
They are sensors indicated for the quantitative determination of beta-hydroxybutyrate (BOHB or beta-cheton) in the whole blood fresh capillary.
Use the GlucoMen areo Beta-Ketone Sensor sensors exclusively with the GlucoMen areo 2K tool.
The GlucoMen areo 2K system has been designed for monitoring and self-control at home of glucose and beta-cheton levels in the blood and can also be used in hospital environment by medical-sanitary personnel.
The system is not intended to be used in the diagnosis or screening of chetonemia (DKA) or use in infants.
Do not change therapy based on the results of chetonemia tests without first consulting your doctor or health care professional.

General characteristics

Chetonemia measurement	beta-hydroxybutyrate (BOHB or beta-cheton) in blood
Enzymatic composition (per cm)2 of a reactive strip for measuring ketonemia	- D-3-hydroxybutyrate dehydrogenase (Pseudomonas sp.) 1.5% w/w - coenzyme (NAD+), 0.7% w/w - redox mediator: 1,10-fenantrolina-5,6-dione, 20,0% w/w - non-reactive substances: 77.8% w/w
Measuring units
Beta-cheton	mmol/L (not editable)
Measurement range
Beta-cheton	0.1-8.0 mmol/L
Response time
Beta-cheton	8 seconds
Sample volume
Beta-cheton	0,8 microL
Ematocrite Acceptability Range
Beta-cheton	automatically compensates for the measurement according to the hematacryte in the range 20-60%
Calibration and traceability	the GlucoMen areo 2K system has been calibrated on the reference values of the plasma determined with a Stanbio Beta-Hydroxybutyrate LiquiColor procedure, Procedures 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 with gravimetric method at the Stanbio Laboratory.
Sample	whole blood capillary fresh
Copy sensors	not required
Igien	automatic expulsion of the reactive strip by dedicated expulsion key
Sample	automatic blood sample suction for capillarity
Operating environment
Beta-cheton	temperature range: 10-40°C relative humidity:

Mode of use
1. Introduce a new sensor GlucoMen areo Beta-Ketone Sensor (light purple color) in the opening for sensor input. The drop symbol will start flashing on the display and the "Keth" ketone symbol will appear on the bottom left. If nothing appears on the display, remove the sensor, insert it again in the opening and wait for the drop symbol to start flashing.
2. Keep the sensor end in contact with the blood drop until the control visor is filled. You will hear an acoustic signal (if enabled) and the display will display a countdown.
3. Read the test results. An acoustic signal will announce the appearance on the screen of the test result with the "Keth" ketone symbol. The symbol will flash until the instrument is shut down.
4. To remove the sensor, press the expulsion button. The tool will turn off.
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 calves.

Warnings
The GlucoMen areo Beta-Ketone Sensor sensors are used exclusively for in vitro diagnostic use (only for external use).
The results may be incorrect if the patient is dehydrated, severely hypertensive, in a state of shock or in a hyperosmolar state.
Do not test patients in critical health conditions.
If the results of the blood chetonemia test are not compatible with the state of health perceived by the patient despite all the instructions indicated in the manual of use of the GlucoMen areo 2K tool, please contact your doctor or healthcare provider.
Never make significant changes to the diabetes control plan without having talked to your doctor before.
Keep the instrument, sensors and other system components out of reach of children. Small parts may be a danger of suffocation.
Handle the sensors with clean and dry hands.
Dispose of the needles and sensors used in accordance with local regulations.
Handling blood can be dangerous; pay extreme attention by handling blood, sensors, hands ( needles) and instrument.

Conservation
Store the aluminum sensor blister at a temperature of 4-30°C; do not freeze and do not refrigerate.
Avoid exposure to moisture, heat and direct sunlight. Do not use sensors over the expiry date as it could cause incorrect results.
Check the expiry date on the aluminum blister.
The GlucoMen areo Beta-Ketone Sensor strips are individually packaged in aluminium blisters, with a validity of 18 months from the date of manufacture.

Format
Pack of 10 pieces.

Cod. 48530