Glucomen Aero B-Ketone Sensor Ketonemia Measurement Strips 10 Pieces

Glucomen Aero B-Ketone Sensor

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 exclusively with the GlucoMen areo 2K instrument.
The GlucoMen areo 2K system is; It was designed for home monitoring and self-monitoring of blood glucose and beta-ketone levels and can be used for home monitoring. It can also be used in a hospital environment by medical personnel.
It is not recommended to use it. The system is intended for use in the diagnosis or screening of blood ketone (DKA) or use in neonates. Do not modify therapy based on blood ketone test results without first consulting your doctor or healthcare professional .

General characteristics
< td>Beta-Ketone< td colspan="2">Range of acceptability hematocrit

Aemia Ketone Measurement	beta-hydroxybutyrate (BOHB or beta-ketone) in the blood
Enzyme composition (per cm2 of a blood ketone test strip	- 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
Units of measure
Beta-ketone	mmol/L (not editable)
Measurement range
0.1-8.0 mmol/L
Time response time
Beta-Ketone	8 seconds
Volume c ample
Beta-ketone	0,8 microL
Beta-ketone	automatically compensates the measurement according to the hematocrit in the range 20-60%
Calibration and traceability	the GlucoMen areo 2K system is the only solution for the 2K system. been calibrated to plasma reference values determined by 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) is suitable for use with the Stanbio kit. been calibrated with a series of standards containing beta-hydroxybutyrate (primary calibrators) prepared gravimetrically at the Stanbio Laboratory.
Sample	fresh capillary whole blood
Sensor coding	not required< /td>
Hygiene	automatic ejection of test strip via dedicated eject button
Sampling	automatic blood sample aspiration by capillarity
Operating environment
Beta-ketone	temperature range: 10- 40°C humidity; relative: <85%

Relative mode: <85%
of use
1. Insert a new GlucoMen areo Beta-Ketone Sensor (light purple color) into the sensor insertion opening.
The symbol of the drop will start with the symbol of the drop. flashing on the display and the ketone symbol "Keth" will appear; lower left.
If nothing appears on the display, remove the sensor, insert it back into the opening and wait for the drop symbol to start flashing.
2. Keep the tip of the of the sensor in contact with the drop of blood until the control visor is full.
You will feel; an acoustic signal (if enabled) and the display will show; a countdown.
3. Read the test results. An acoustic signal will announce the the appearance on the screen of the test result with the ketone symbol " Keth". The symbol will flash. until the instrument is switched off.
4. To remove the sensor, press the eject button.
The meter will turn off.
Do not use the GlucoMen areo Beta-Ketone Sensors to test samples taken from alternative sites: only use fresh capillary blood taken from the fingertips.

< strong>Warnings
The GlucoMen areo Beta-Ketone Sensors are for in vitro diagnostic use only (external use only).
Results may be incorrect if the patient is in vitro. dehydrated, severely hypertensive, in a state of shock, or in a hyperosmolar state.
Do not test critically ill patients.
If blood ketone test results do not match the patient's perceived state of health even if you have followed all the instructions in the GlucoMen areo 2K instrument user manual, contact your doctor or healthcare professional.
Never make any significant changes to your diabetes control plan without first discussing it with your doctor.
Keep the instrument, sensors and other system components out of the reach of children.
Small parts may present a choking hazard.
Handle sensors with clean, dry hands.
Dispose of lancets (needles) and used sensors in accordance with local regulations.
/>Handling blood can be dangerous. be dangerous; pay extreme attention when handling the blood, the sensors, the lancets (needles) and the instrument.

Format
Pack of 10 pieces.