Description
In vitro medical-diagnostic device.
Sensors for self-monitoring of ketonemia with the GlucoMen areo 2K instrument.
These sensors are indicated for the quantitative determination of beta-hydroxybutyrate (BOHB or beta-ketone) in fresh capillary whole blood.
Use GlucoMen areo Beta-Ketone Sensors exclusively with the GlucoMen areo 2K instrument.
The GlucoMen areo 2K system is designed for monitoring and self-monitoring of blood glucose and beta-ketone levels at home and can also be used in hospitals by medical and healthcare personnel.
The system is not intended for use in the diagnosis or screening of ketonemia (DKA) or for use in neonates.
Do not change therapy based on ketonemia test results without first consulting your doctor or healthcare professional.

General characteristics

Ketonemia measurement	beta-hydroxybutyrate (BOHB or beta-ketone) in blood
Enzymatic composition (per cm2 of a test strip for ketonemia measurement	- 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
Beta-ketone	mmol/L (not modifiable)
Measurement range
Beta-ketone	0.1-8.0 mmol/L
Response time
Beta-ketone	8 seconds
Sample volume
Beta-ketone	0.8 microL
Hematocrit acceptability range
Beta-ketone	automatically compensates the measurement based on hematocrit in the range 20-60%
Calibration and traceability	the GlucoMen areo 2K system has been calibrated against plasma reference values determined using a Stanbio Beta-Hydroxybutyrate LiquiColor procedure, Procedure No. 2440 (Stanbio Laboratory, 1261 North Main Street, Boerne, Texas 78006). The analyzer employing the Stanbio kit (secondary reference measurement procedure) has been calibrated with a series of standards containing beta-hydroxybutyrate (primary calibrators) prepared by gravimetric method at Stanbio Laboratory.
Sample	fresh capillary whole blood
Sensor coding	not required
Hygiene	automatic test strip ejection using a dedicated ejection button
Sampling	automatic aspiration of the blood sample by capillarity
Operating environment
Beta-ketone	temperature range: 10-40°C relative humidity: <85%

Instructions for use
1. Insert a new GlucoMen areo Beta-Ketone Sensor (light purple color) into the sensor insertion slot. 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, reinsert it into the slot and wait for the drop symbol to start flashing.
2. Hold the tip of the sensor against the blood drop until the control window is filled. An acoustic signal will sound (if enabled) and the display will show a countdown.
3. Read the test results. An acoustic signal will announce the appearance of the test result on the screen with the ketone symbol Keth. The symbol will flash until the instrument turns off.
4. To remove the sensor, press the eject button. The instrument will turn off.
Do not use GlucoMen areo Beta-Ketone Sensors to test samples taken from alternative sites: use only fresh capillary blood taken from fingertips.

Warnings
GlucoMen areo Beta-Ketone Sensors are for in vitro diagnostic use only (for external use only).
Results may be incorrect if the patient is dehydrated, severely hypertensive, in shock or in a hyperosmolar state.
Do not test critically ill patients.
If the blood ketonemia test results are not compatible with the patient's perceived health status despite following all instructions in the GlucoMen areo 2K instrument's user manual, contact your doctor or healthcare provider.
Never make significant changes to your diabetes management plan without first discussing it with your doctor.
Keep the instrument, sensors and other system components out of reach of children. Small parts can pose a choking hazard.
Handle sensors with clean, dry hands.
Dispose of used lancets (needles) and sensors in accordance with local regulations.
Handling blood can be dangerous; exercise extreme caution when handling blood, sensors, lancets (needles) and the instrument.

Storage
Store the aluminum blister pack of sensors at a temperature of 4-30°C; do not freeze or refrigerate.
Avoid exposure to humidity, heat and direct sunlight. Do not use sensors beyond the expiration date as this may lead to incorrect results.
Check the expiration date on the aluminum blister pack.
GlucoMen areo Beta-Ketone Sensors are individually packaged in aluminum blister packs, with a validity of 18 months from the date of manufacture.

Format
Pack of 10 pieces.

Code 48530