Description
Test strips designed to measure beta-ketone in fresh capillary whole blood from the fingertip. The test strips are intended for use outside the body ( in vitro diagnostic use) and are intended for self-testing or healthcare professional use. Healthcare professionals may also use venous blood samples, provided that venous whole blood samples are used within 30 minutes of collection. These systems are not intended for the diagnosis of diabetes mellitus, but should be used as an aid in monitoring the effectiveness of diabetes management programs.
The package does not contain:
-FreeStyle OptiumNeo, FreeStyle Optium, Optium or Optium Xceed Meter (not all products are available in all countries);
-MediSense or Optium Glucose and Ketone Control Solutions;
-User manual;
-Lancing device and lancets.

Composition
Beta-hydroxybutyrate Dehydrogenase (Pseudomonas sp), NAD (free acid form), Phenanthroline quinone, non-reactive ingredients.

How to use
Before obtaining a drop of blood, make sure your fingertips are clean, dry, and warm. To warm them, wash your hands in warm water. Prop your arm upside down before pricking your fingertip to encourage blood flow. Avoid pressing your fingertips too hard. Immediately apply the drop of blood to the test strip.
1) Remove the test strip from the purple foil packet. Open the strip packet by tearing the notch.
2) Insert the contact bars at the end of the test strip into the meter's test port. Gently push the test strip in until it stops. The meter will turn on automatically. (If using an Optium or Optium Xceed Meter, check that "LOT 75001" or "CODE 75001" appears on the display. If it does not, contact customer service.)
3) Obtain a drop of blood. Follow the instructions for use on the lancing device packaging.
4) Place the drop of blood in the white target area at the end of the test strip. The blood will be absorbed into the test strip.
The meter displays your beta-ketone blood result in 10 seconds. If the countdown doesn't begin, you may not have applied enough blood to the test strip. Apply a second drop of blood within 30 seconds of the first. If the countdown still doesn't begin, or if more than 30 seconds have passed, discard the test strip, turn off the meter, and repeat the steps.
Normally, blood beta-OHB levels should be less than 0.6 mmol/liter. Beta-OHB levels may increase if a person fasts, engages in vigorous exercise, has diabetes, or is ill. If your blood beta-ketone result is 0.0 mmol/liter and your blood glucose result is 16.7 mmol/liter or higher, repeat both the ketone and glucose tests with new test strips. If the same message appears again or the result doesn't reflect how you feel, consult your doctor.

Warnings
The test strip has not been evaluated for alternative site testing.
The test strip is not intended for use with arterial, neonatal, serum, or plasma specimens.
The hematocrit range is 30%-60%.
Test results may be falsely low if the patient is severely dehydrated, or severely hypotensive, in shock, or in a hyperglycemic-hyperosmolar state.
The following substances have no significant effect on blood beta-ketone results:
-Captopril up to 23 mcmol/liter (500 mcg/dl)
-L-DOPA up to 30 mcmol/liter (600 mcg/dl)
-Dopamine up to 5.9 mcmol/liter (90 mcg/dl)
-Gentisic acid up to 117 mcmol/liter (1.8 mg/dl)
-Paracetamol up to 1.7 mmol/liter (25 mg/dl)
-Uric acid up to 1.4 mmol/liter (24 mg/dl)
-Ascorbic acid up to 227 mcmol/liter (4 mg/dl)
-Unconjugated bilirubin up to 342 mcmol/liter (20 mg/dl)
-Cholesterol up to 12.9 mmol/liter (500 mg/dl)
-Triglycerides up to 21.2 mmol/liter (1,875 mg/dl).

Format
Package containing:
-10 test strips
-Instructions for use.

Cod. 9907875