Sensors for self-monitoring of blood ketones with the GlucoMen areo 2K meter.
Indications
GlucoMen areo B-Ketone Sensor These sensors are indicated for the quantitative determination of beta-hydroxybutyrate (BOHB or beta-ketone) in fresh capillary whole blood.
Use the GlucoMen areo Beta-Ketone Sensor exclusively with the GlucoMen areo 2K meter.
The GlucoMen areo 2K system is designed for home monitoring and self-monitoring of blood glucose and beta-ketone levels and can be used in combination with other blood glucose and beta-ketone sensors. It can also be used in a hospital setting by healthcare professionals.
The system is not intended for use in the diagnosis or screening of blood ketonemia (DKA) or for use in newborns.
Do not change therapy based on blood ketonemia test results without first consulting your doctor or healthcare professional.
| Reference values |
| Measurement of blood ketonemia | beta-hydroxybutyrate (BOHB or beta-ketone) in blood |
| Enzyme composition (per cm2 of a test strip for measuring blood 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 |
| Beta-ketone | mmol/L (not editable) |
| Measuring range |
| Beta-ketone | 0.1-8.0 mmol/L |
| Response time |
| Beta-ketone | 8 seconds |
| Sample volume |
| Beta-ketone | 0.8 microL |
| Acceptability range Hematocrit |
| Beta-ketone | automatically compensates for hematocrit in the range of 20-60% |
| Calibration and Traceability | 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 set of standards containing beta-hydroxybutyrate (primary calibrators) prepared gravimetrically at Stanbio Laboratory. |
| Sample | fresh capillary whole blood |
| Sensor coding | not required |
| Hygiene | automatic ejection of the test strip via dedicated ejection button |
| Sampling | automatic aspiration of the blood sample by capillary action |
| Operating environment |
| Beta-ketone | temperature range: 10-40°C
relative humidity: <85% |
How to use
- Insert a new GlucoMen areo Beta-Ketone Sensor (light purple) into the test strip port. The drop symbol will start flashing on the display and the ketone symbol "Keth" will appear in the lower 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.
- Keep the tip of the sensor touching the drop of blood until the control window fills. You will hear a beep (if enabled) and the display will show a countdown.
- Read the test results. A beep will announce the appearance of the test result with the ketone symbol "Keth" on the screen. symbol will flash until the meter turns off.
- To remove the sensor, press the eject button. The meter will turn off.
Do not use the GlucoMen areo Beta-Ketone Sensor test strips for testing samples from alternative sites: use only fresh capillary blood from the fingertip.
Warnings
The GlucoMen areo Beta-Ketone Sensor test strips 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 patients in critical health conditions.
If the blood ketone test results are not consistent with the patient's perceived health status despite following all the instructions in the GlucoMen areo 2K meter user manual, contact your doctor or healthcare professional. Reference.
Never make significant changes to your diabetes management plan without first discussing it with your doctor.
Keep the meter, sensors, and other system components out of the reach of children. Small parts can be a choking hazard.
Handle sensors with clean, dry hands.
Dispose of used lancets (needles) and sensors according to local regulations.
Handling blood can be dangerous; use extreme caution when handling blood, sensors, lancets (needles), and the meter.
Storage
Store the foil blister pack of sensors at 40-30°C (39-86°F); do not freeze or refrigerate.
Avoid exposure to moisture, heat, and direct sunlight. Do not use sensors past their expiration date as it may cause inaccurate results.
Check the expiry date shown on the aluminum blister.
GlucoMen areo Beta-Ketone Sensor strips are individually packaged in aluminum blisters, with a shelf life of 18 months from the manufacturing date.
Format
10 sensors
Product Code:FRCM131035
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This product has been on sale since 04/06/2020
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