Description
GlucoMen
air sensor
Description
In vitro diagnostic medical device.
Sensors for the quantitative determination of glucose levels in fresh capillary whole blood; to be used exclusively with the GlucoMen areo 2K instrument.
The sensors are designed for monitoring and self-monitoring of blood glucose levels in people with diabetes mellitus; they can also be used in hospital settings by healthcare professionals.
It is not intended for use in the diagnosis or screening of diabetes or for use in newborns.
Do not change your treatment based on test results without first consulting your doctor or health care professional.
General characteristics
How to use
1. Insert a new GlucoMen areo Sensor (white) into the sensor port. The drop symbol will start flashing on the display and the glucose symbol "Glu" will appear in the bottom 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.
For information on how to use the lancing device, read the instructions for use provided with it.
2. Hold the tip of the sensor in contact with the drop of blood until the control window fills. You will then 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 glucose symbol "Glu".
4. To remove the sensor, press the eject button. The instrument will turn off.
Warnings
Keep the instrument, sensors and other components out of the reach and sight of children. Small parts may pose a choking hazard.
Handle the bottle and sensors with clean, dry hands.
Dispose of the used bottle and sensors according to local regulations.
Handling blood can be dangerous: use extreme caution when handling blood, sensors, lancets, and the meter.
Conservation
Store the sensor bottle in a dry place, at a temperature of 4-30°C. Do not freeze. Avoid heat and direct sunlight.
Store all unused sensors in the original bottle and close the cap tightly after removing one to preserve the quality of the sensor. Do not transfer sensors to other containers.
Do not use sensors beyond their expiration date.
Do not use the sensors more than 12 months after first opening their bottle. It is recommended to write the disposal date on the label (first opening date + 12 months).
The strips in closed packaging have a validity of 24 months from the date of manufacture.
Format
Pack of 50 sensors.
Code 49198
In vitro diagnostic medical device.
Sensors for the quantitative determination of glucose levels in fresh capillary whole blood; to be used exclusively with the GlucoMen areo 2K instrument.
The sensors are designed for monitoring and self-monitoring of blood glucose levels in people with diabetes mellitus; they can also be used in hospital settings by healthcare professionals.
It is not intended for use in the diagnosis or screening of diabetes or for use in newborns.
Do not change your treatment based on test results without first consulting your doctor or health care professional.
General characteristics
| Blood glucose measurement | specificity for beta-D-glucose in blood |
| Enzyme composition (per cm2 ) of a test strip for measuring blood glucose | - glucose oxidase (from Aspergillus niger ), 3.5% - mediator: hexacyanoferrate (III) ion, 17.5% - non-reactive substances, 79% |
| Unit of measurement | |
| Glucose | mg/dL (not modifiable) |
| Measuring range | |
| Glucose | 20-600 mg/dL |
| Response time | |
| Glucose | 5 seconds |
| Sample volume | |
| Glucose | 0.5 microL |
| Acceptable Hematocrit Range | |
| Glucose | automatically corrects the measurement based on the hematocrit (10-70%) |
| Correlation | plasma equivalent |
| Sample | fresh capillary whole blood |
| Sensor Coding | self-coding |
| Hygiene | Automatic ejection of the test strip via dedicated ejection button |
| Sampling | automatic blood sample aspiration by capillary action |
| Use of alternative sites (AST) | allowed (palm and forearm) |
| Operating environment | Temperature range: 5-45°C Humidity: 20%-90% (non-condensing) |
How to use
1. Insert a new GlucoMen areo Sensor (white) into the sensor port. The drop symbol will start flashing on the display and the glucose symbol "Glu" will appear in the bottom 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.
For information on how to use the lancing device, read the instructions for use provided with it.
2. Hold the tip of the sensor in contact with the drop of blood until the control window fills. You will then 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 glucose symbol "Glu".
4. To remove the sensor, press the eject button. The instrument will turn off.
Warnings
Keep the instrument, sensors and other components out of the reach and sight of children. Small parts may pose a choking hazard.
Handle the bottle and sensors with clean, dry hands.
Dispose of the used bottle and sensors according to local regulations.
Handling blood can be dangerous: use extreme caution when handling blood, sensors, lancets, and the meter.
Conservation
Store the sensor bottle in a dry place, at a temperature of 4-30°C. Do not freeze. Avoid heat and direct sunlight.
Store all unused sensors in the original bottle and close the cap tightly after removing one to preserve the quality of the sensor. Do not transfer sensors to other containers.
Do not use sensors beyond their expiration date.
Do not use the sensors more than 12 months after first opening their bottle. It is recommended to write the disposal date on the label (first opening date + 12 months).
The strips in closed packaging have a validity of 24 months from the date of manufacture.
Format
Pack of 50 sensors.
Code 49198
