Description
GlucoMen
B-Ketone Sensor aero
Description
In vitro diagnostic medical device.
Sensors for self-monitoring of ketonemia with the GlucoMen areo 2K instrument.
They are sensors indicated for the quantitative determination of beta-hydroxybutyrate (BOHB or beta-ketone) in fresh capillary whole blood.
Use the GlucoMen areo Beta-Ketone Sensor only 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 also be used in hospital settings by healthcare professionals.
The system is not intended for use in the diagnosis or screening of DKA or for use in neonates.
Do not change your therapy based on your blood ketone test results without first consulting your doctor or health care professional.
General characteristics
How to use
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
The GlucoMen areo Beta-Ketone Sensor is intended 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 your perceived health status despite following all the instructions in the GlucoMen areo 2K meter user manual, contact your doctor or healthcare professional.
Never make any significant changes to your diabetes management plan without first talking to your doctor.
Keep the instrument, sensors, and other system components out of the reach of children. Small parts may pose a choking hazard.
Handle the 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.
Conservation
Store the sensor foil blister at 4-30°C; do not freeze or refrigerate.
Avoid exposure to moisture, heat and direct sunlight. Do not use the sensors beyond the expiration date as it may cause incorrect results.
Check the expiry date on the aluminium blister.
GlucoMen areo Beta-Ketone Sensor strips are individually packaged in aluminium blisters, with a shelf life of 18 months from the date of manufacture.
Format
Pack of 10 pieces.
Code 48530
In vitro diagnostic medical device.
Sensors for self-monitoring of ketonemia with the GlucoMen areo 2K instrument.
They are sensors indicated for the quantitative determination of beta-hydroxybutyrate (BOHB or beta-ketone) in fresh capillary whole blood.
Use the GlucoMen areo Beta-Ketone Sensor only 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 also be used in hospital settings by healthcare professionals.
The system is not intended for use in the diagnosis or screening of DKA or for use in neonates.
Do not change your therapy based on your blood ketone test results without first consulting your doctor or health care professional.
General characteristics
| Measurement of blood ketonemia | beta-hydroxybutyrate (BOHB or 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 | |
| Beta-ketone | mmol/L (not modifiable) |
| Measuring range | |
| Beta-ketone | 0.1-8.0 mmol/L |
| Response time | |
| Beta-ketone | 8 seconds |
| Sample volume | |
| Beta-ketone | 0.8 microL |
| Acceptable Hematocrit Range | |
| Beta-ketone | automatically performs measurement compensation based on hematocrit in the range 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 series of beta-hydroxybutyrate-containing standards (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 blood sample aspiration by capillary action |
| Operating environment | |
| Beta-ketone | Temperature range: 10-40°C relative humidity: <85% |
How to use
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
The GlucoMen areo Beta-Ketone Sensor is intended 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 your perceived health status despite following all the instructions in the GlucoMen areo 2K meter user manual, contact your doctor or healthcare professional.
Never make any significant changes to your diabetes management plan without first talking to your doctor.
Keep the instrument, sensors, and other system components out of the reach of children. Small parts may pose a choking hazard.
Handle the 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.
Conservation
Store the sensor foil blister at 4-30°C; do not freeze or refrigerate.
Avoid exposure to moisture, heat and direct sunlight. Do not use the sensors beyond the expiration date as it may cause incorrect results.
Check the expiry date on the aluminium blister.
GlucoMen areo Beta-Ketone Sensor strips are individually packaged in aluminium blisters, with a shelf life of 18 months from the date of manufacture.
Format
Pack of 10 pieces.
Code 48530
