Description
A blood glucose monitoring system, designed for easy blood glucose control and to help keep values under control.
The Iris Evolution X blood glucose test is based on measuring the electrical current caused by the reaction of glucose with the reagents on the test strip's electrode.
The blood sample is drawn into the tip of the test strip by capillary action. The glucose in the sample then reacts with an enzyme and a mediator, generating electrons, which produce a current proportional to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The instrument is calibrated to display plasma concentration results.
Intended for external use (in vitro diagnostic use) by people with diabetes and by healthcare professionals in the clinical field, in order to effectively monitor diabetes. The system should not be used for the diagnosis of diabetes.

Technical Information

Measurement range	10 to 600 mg/dL (0.6-33.3 mmol/L)
Calibration	Plasma-equivalent
Sample	Fresh whole blood (capillary, venous, arterial, and neonatal)
Sample volume	Approximately 0.5 mcL
Test duration	Approximately 5 seconds
Power source	Two 1.5 V AAA LR03 batteries
Glucose unit of measure	The meter is preset to millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) depending on the country standard
Memory	1,000 memories with date and time
Automatic shutdown	2 minutes after last action
Dimensions	93.5 mm x 60.5 mm x 20 mm
Display dimensions	47 mm x 37 mm
Weight	Approximately 67.4 g (with battery installed)
Temperature	5-45 °C
Operating relative humidity	10-90% (non-condensing)
Hematocrit range	0-70%
Bluetooth	Version 4.2

How to use
Properly set up the meter and have all necessary materials on hand before starting the test (the Iris Evolution X meter, Iris Evo test strips, and the Iris lancing device with its lancets).

Wash and dry your hands thoroughly before starting the test.
Remove a test strip from the vial or aluminum foil pouch. Carefully close the vial cap immediately after removing the test strip. Insert the test strip into the meter in the direction of the arrow. The meter will turn on after an audible signal.
A symbol with a test strip and a flashing blood drop appears on the display, indicating that the meter is ready for testing.
To obtain a fingertip blood sample, adjust the penetration depth to reduce pain.
Remove the cap from the lancing device. Insert a sterile lancet into the lancing device and push it until the lancet is fully seated in the device. Hold the lancet firmly in the lancing device and twist off the lancet's safety tab, then pull the safety tab off the lancet. Keep the safety tab for later disposal of the used lancet. Carefully place the cap back on the lancing device. Avoid contact with the exposed needle. Make sure the cover is fully screwed onto the device.
Adjust the penetration depth by rotating the lancing device's cap. There are a total of 5 penetration depth settings. To reduce pain, use the lowest setting that still allows a sufficient blood drop.
Pull back the end to prime the lancing device. The device will click to indicate that the lancing device is now loaded and ready to obtain a blood drop.
Press the lancing device. Push the release button to prick your fingertip. You should feel a click when the lancing device activates. Gently massage your finger from the base to the tip to obtain the desired blood volume. Avoid touching the blood drop. To reduce pain, it is recommended to prick the side of your finger. Perform the test immediately after obtaining the necessary amount of blood. Immediately bring the tip of the test strip into contact with the blood drop. The blood will be drawn into the test strip through the tip. Ensure that the test strip channel is completely filled. Keep the tip of the test strip in contact with the blood drop until the meter beeps. If the blood sample does not fill the test strip channel, do not add a second blood drop. Discard the used test strip and retest using a new test strip.
The meter will start a 5-second countdown and the result will be displayed after an audible signal. The test result will be automatically saved in the device's memory. Please do not touch the test strip during the countdown as this may cause an error in the result.
You can remove the used test strip by sliding the strip ejector lever forward. The instrument automatically turns off after an audible signal. Unscrew the lancing device cap. Place the lancet safety tab on a flat surface; carefully insert the lancet needle into the safety tab. Press the release button to ensure the lancing device is unloaded. Slide the eject button forward to eject the used lancet. Replace the lancing device cap.

Interpretation of results
Blood glucose values vary depending on food intake, medication dosages, health, stress, or exercise. Ideally, the goal is to control the glucose level as close as possible to a normal blood glucose level (non-diabetic).

	Range (mg/dL)	Range (mmol/L)
Before a meal	80-130 mg/dL	4.4-7.2 mmol/L
1-2 hours after start of meal	less than 180 mg/dL	less than 10 mmol/L

Expected blood glucose levels for most non-pregnant adults with diabetes.

If the blood glucose reading is less than 50 mg/dL (2.8 mmol/L) or if LO [less than 10 mg/dL (0.6 mmol/L)] is displayed on the meter, contact your doctor as soon as possible.
If the test result is greater than 250 mg/dL (13.9 mmol/L) or if HI [greater than 600 mg/dL (33.3 mmol/L)] is displayed on the meter, contact your doctor as soon as possible.

Warnings
The Iris Evolution X meter, Iris® Evo test strips, and control solutions have been designed, tested, and their effectiveness proven to provide accurate blood glucose measurements. Do not use components from other brands.
Fresh capillary blood can be collected in tubes containing sodium heparin or lithium heparin if the blood sample is used within 10 minutes. Do not use sodium fluoride/oxalate or other anticoagulants or preservatives.
Use whole blood only. Do not use with serum or plasma samples.
Very high hematocrit levels (above 70%) can cause inaccurate results.
Abnormally high levels of vitamin C and other reducing substances will produce inaccurate blood glucose results.
The system can accurately read glucose in whole blood in the range of 10 to 600 mg/dL (0.6-33.3 mmol/L).
Fatty substances [triglycerides up to 3,000 mg/dL (166.7 mmol/L) or cholesterol up to 500 mg/dL (27.7 mmol/L)] have no significant effect on blood glucose test results.
Seriously ill subjects should not perform blood glucose testing with the Iris Evolution X blood glucose monitoring system.
Blood samples from patients in shock, with severe dehydration, or from hyperosmolar patients (with or without ketosis) have not been tested and are not recommended for testing with the Iris Evolution X system.
Carefully dispose of blood samples and materials. Treat all blood samples as if they were infectious materials. Follow appropriate precautions and comply with all local regulations when disposing of materials.

Format
1 piece

Code. VGM77