IMPORTANT:

Read this package insert and the user’s manual of the  Multi-Monitoring System before testing your total cholesterol with these test strips. The user’s manual contains all the information you need to perform a cholesterol test.

Intended Use

Total Cholesterol Test Strips are used with the Multi-Monitoring Meters and Systems for quantitatively measuring total cholesterol in fresh capillary whole blood or venous blood. Total Cholesterol Test Strips and the associated meters are intended for use outside the body (in vitro diagnostic use) by people at home and health care professionals in the clinical setting.

Test Principle

Based on biosensor principle. Total cholesterol in the blood sample mixes with special chemicals on the test strip and a small electrical current is produced. This current is measured by the ACCU-ANSWER® Multi-Monitoring Meters and displayed as your total cholesterol result. The strength of this current changes with the amount of total cholesterol in the blood sample.

Ingredients

The test strip is composed of plastic strip, electrode layer, reagent layer and cover layer.

thickening. Wash your hands thoroughly with warm, soapy water. Rinse and dry, if you use the alcohol pad to sterilize your finger, you should wait the alcohol evaporating completely. Let your arm droop for 10-15 seconds will be helpful to sampling. Gently squeeze and /or message your fingertip until a round drop of blood of at least 1.5 microliter forms on your finger tip. Do not squeeze excessively on the puncture site.

Step 2 Remove a new test strip from bottle and replace cap immediately, insert the test strip into the test port, make sure the three contact bars are facing you. Push the strip in as far as it will go, this turns the meter on automatically, the code number will flash on the display for three seconds, make sure the code number on the display matches the code number on the test strip vial, if you miss seeing the code number, remove the test strip and reinsert it into the meter.

Step 3 CHO and flashing blood drop symbol appear on the display, make sure it must show CHO, or please discard the test strip and change a new test strip, touch and hold the drop of blood to the narrow channel in the top edge of the test strip, blood will be drawn into the strip. Remove away the finger after you hear the warning tone.

Step 4 If the confirmation window does not fill completely before the meter begins to count down, do not add more blood to the test strip; discard the test strip and retest. If the confirmation window is not full, you may get an error message or an inaccurate test result.

Step 5 The meter begins to count down from 5 to 0, then your total cholesterol level appears on the display.

Step 6 After getting a result, turn the meter off by press the ejection button to remove the test strip.

Please don’t use expired and contaminated test strip, it will cause inaccurate test result.

Abnormally high concentrations of reducing substances such as ascorbic acid (vitamin C) in blood will cause inaccurately high results.

If you’re total cholesterol test results fall outside the expected test results or if you are experiencing symptoms that are not consistent with your test results, please repeat a test, if you still get an unexpected test result, please contact your healthcare professional.

If your total cholesterol test result is lower than 2.58(103mg/dL), LO will appear on the meter display.This indicates severe low total cholesterol. If your total cholesterol test result is higher than 10.34(413mg/dL), HI will appear on the meter display.This indicates severe high total cholesterol. You should repeat a test, if still get the same result, please contact your healthcare professional.

Limitation

The test strips should not be used for the testing newborns.

The test strips are for single use only. Do not reuse.

Use only fresh capillary whole blood. Do not use serum or plasma.

Performance Characteristics

 Measurement range:

The measurement range of the system is 2.58-10.34mmol/L (103-413mg/dL)

 Precision

System precision according to In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus (GB/T 19634-2005)

Total cholesterol concentration intervals for intermediate measurement precision evaluation (table 1)