H12 Hemoglobin Test Strip
Prior to the use of test strip, please read this Insert and URIT-12 Hemoglobin Meter Operating Manual carefully.
For in vitro diagnostic use only
¡¾INTENDED USE¡¿
H12 Hemoglobin Test Strips are applied on URIT-12 Hemoglobin Meter, for the quantitative measurement of total hemoglobin in capillary and venous whole blood. The test is intended for use by health care professionals only, not to be used for patient self-testing.
¡¾INGREDIENTS¡¿
Potassium ferricyanide, surfactant, etc.
¡¾STRUCTURE¡¿
Urit 12 Hemoglobin Test Strips mainly consists of a basal strip affixed with reagent paper. See the structure as follows:
1.plastic basal strip 2. sample spot 3. test membrane ( containing reagent ) 4. fix position segment
¡¾BLOOD SAMPLE COLLECTION¡¿
¡¤Fresh or EDTA-anticoagulated capillary or venous whole blood may be used.
¡¤If an EDTA-treated sample is refrigerated, allow it to come to the room temperature before testing. EDTA-treated blood samples should be mixed using end to end inversions at least 8 times prior to use, and should be tested within 24 hours.
¡¤Do not use the haemolytic sample, anticogulants other than EDTA are not recommended for use.
¡¾STORAGE AND PREPARATION¡¿
1.U-12 Hemoglobin Test Strips should be stored at 0¡æ ~ 30¡æ dry and dark places, 2¡æ ~ 8¡æ is the best storage environment temperatures recommended . Avoid direct sunlight and high temperatures, must not be frozen. If the container was stored in refrigerated before first use, please don¡¯t take it back into the refrigerator again after first use.
2.U-12 Hemoglobin Test Strips are ready to use. No additional preparation is required.
3. Enclosed desiccants with test strip. Remove only those strips needed for testing. The remaining test strips should be resealed in their original container and used up in 3 months after first use. Do not use test strips and throw away after expiry date.
4.Use the strip immediately once taking it out of the container, otherwise the result will be incorrect.
5.Do not fold or cut the test strip.
6.Used test strips cannot be used again, dispose them as normal medical waste.
¡¾OPERATING INSTRUCTIONS¡¿
¡¤Before doing any test, please refer to the Operator Manual for detailed instructions.
1. Requirement:
URIT-12 Hemoglobin Meter, U-12 Hemoglobin Test Strip, blood collection pen, new one-off disinfected blood collection needle.
2. Test steps:
1) Turn the meter on and input the Lot Code. Check the Lot Code displaying on the meter to ensure it to match the Lot Code printed on the test strip container. Otherwise, the result is incorrect.
2) Massage the patient''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''s finger from the knuckle up to the tip to stimulate blood flow. Clean the sample area with alcohol and wipe it dry with a sterile gauze pad.
3) Insert the test strip into the strip holder with the notched end in first and the hole facing up.
4) Pierce the underside of the fingertip by needle, let the blood flow naturally. When a blood symbol displays, apply a drop of blood to the strip spot quickly, and ensure the spot is covered by sufficient blood completely. Blood sample volume should be 13 - 15¦ÌL.
5) The meter starts the test automatically after the blood sample disperses. Once the test is in process, do not disturb or move the meter or test strip, or press any key. The test result will display within 30 seconds.
¡¤Notice:
1. Check the expiry date of test strip before test, do not use the test strip after expiry date.
2. A specific Lot Code is assigned to each lot of U-12 Hemoglobin Test Strip. Check the Lot Code displaying on the meter to ensure it match the Lot Code printed on the test strip container. For the URIT-12 Hemoglobin Meters which supporting the code card (the only way to enter the Lot code of the test strips for these meters), please refer to URIT-12 Hemoglobin Meter Operating Manual, insert the code card to input the lot code for the test strips.
¡¾OPERATION PRINCIPLE¡¿
The test strip utilizes Dry Chemistry Colorimeter Method (Azido methaemoglobin Method). When a drop of whole blood is applied to the test spot on the strip, blood immediately disperses within the membrane, contacting the reagent. The meter''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''s optical detectors automatically measure the change in membrane reflectance. The intensity of reflectance is inversely proportional to the hemoglobin concentration.
¡¾MEASURING RANGE¡¿
The measuring range of test strip is from 4.0g/dL to 24.0g/dL. Results under 4.0g/dL and over 24.0g/dL will display as¡°Lo¡± and ¡°Hi¡± respectively so as to indicate that the result is out of range.
¡¾NORMAL RANGE OF REFERENCE VALUES¡¿
Adult males: 13.5g/dL¨C¨C 18.0g/dL
Adult females: 12.0g/dL¨C¨C 16.0g/dL
Infants: from 14.5g/dL¨C¨C 22.5g/dL after birth to 11.1g/dL¨C¨C 14.1g/dL 6 months old.
Children: gradual change from infant to adult levels.
* Each clinical site should establish its own reference ranges.
¡¾NOTICE¡¿
1. Same as all diagnostic tests, hemoglobin test results should be evaluated with the specific patient''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''s condition. Any results demonstrating the inconsistency with the patient''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''s clinical status should be repeated or supplemented with additional test data.
2. Do not touch the test membrane by hand.
3. U-12 Hemoglobin Test Strips are one-off product, do not use again.
¡¾PRECAUTIONS¡¿
1. The suitable operation temperature range of H12 Hemoglobin Test Strip is 15¡æ to 30¡æ. Do not expose it to the extreme temperature, as such exposure could affect result.
2. Blood plasma and serum should not be used in this system. No result will be obtained from testing with arterial blood.
3. Insufficient blood sample will affect the result. Hereby, check whether the reverse of strip spot is dyed completely or not. If the splash is incomplete, it means the blood is insufficient, do not accept this result.
4. Other than EDTA are not recommended for use, such as sodium citrate and heparin.
5. High bilirubin, cholesterol, triglycerides or others may interfere the test.
¡¾SPECIFICATION¡¿ 25 pieces
¡¾EXPIRY DATE¡¿ 18 months
