File - Easytouch Uric Acid and Hemoglobin Home Blood
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1. Materials Needed to Test Your Hemoglobin aEasyTouch Series Hemoglobin Meter _ sEasyTouch Hemoglobin Test Strips REF SH 102 25 aLancets not included Puncturer lancing device aAlcohol swab not included sEasyTouch Series Hemoglobin Monitoring System User s Manual alog Book Sample Collection and Preparation The EasyTouch Seres Hemagiobin Monitoring System is designed to determine hemoglobin level in fresh capillary whole blood i e from fingertip To obtain a drop of blood follow these steps Step 1 Wash your hands with soap and warm water then dry thoroughly Step 2 Prepare puncturer according to the instructions Step 5 Using an alcohol swab and making sure that your finger is completely dry Before lancing your finger Step 4 Using the puncturer to obtain a drop of blood Avoid excessive squeezing of the puncture site Code Strips Procedure When you use a new vial of tes strips the EasyTouch Series Hemoglobin Meter muside calibrated with the new code key packaged in the box far obtaining an accurate hemoglobin test result afin the CODE number on the vial of EasyTouch Hemoglobin Test Strips alnsert the code key into the code key slot of the meter Make sure the code number is facing up alnsert a test strip into the test strip slot of the meter it will automatically turn on and display the code number on the LCD screen alt is important that the code number on the meter matches2. the code number on the vial of test strips Blood Hemoglobin Testing Wash and dry your hands thoroughly Insert the lancet into the puncturer Prepare the puncturer according lo the instructions To test your hemoglobin level follow these steps Step 1 Insert Test Strip Remove a test strip from the vial and immediatly seal the vial cap Insert the test strip into the test strip slot and the meter will turn on automatically Code number will appear briefly Then make sure the gode number on the screen matches the code number on the test strip vial If the code number does not match code the meter correctly Step 2 Apply sample Obtain a drop of blood using the sample collection procedure described above When e symbol is displayed applying your blood sample to the sample target area of the test strip The blood is automatically drawn into the reaction zone of lest strips The meter will begin measuring hemoglobin level Step 3 Read the result after 6 seconds Your hemoglobin measurement will appear on the screen after 6 seconds The results will be automatically stored Turn the meter off by removing the test strip For detailed information on the procedure please refer to the EasyTouch Series Hemoglobin Monitoring System User s Manual Quality Control It is recommended to check the performance of EasyTouch Series Hemoglobin Monitoring System under the following conditions a When your hemoglobin test results
3. are not consistent with what you expected or when you feel your results are not accurate uWhenever your suspec that the meter or test strips are nol working correctly aWhen you drop the meter aWhen you begin to use a new vial of test strips To check the performance of the meter test strips and your testing technique run the control solution test by following the instructions detailed in Easy Touch Series Hemoglobin Monitorning System User s Manual The EasyTouch Hemoglobin Control Solutions are only designed for using with EasyTouch Hemoglobin Test Strips Other control solutions may provide incorrect results When EasyTouch Hemoglobin Control Solution test results fall within the expected ranges printed on the test strip vial label the system is performing properly If your control solution test resulls are not within the expected range repeat the contro solution test DO NOT use the system to test your blood until you get a control solution test result within the expected range Results that fall outside the range may be caused by mError in performing the test wExpired or contaminated control solution mlmproper coding of the meter mTest Strip deterioration Meter malfunction Test Results The unit of hemoglobin test results displayed on the screen is either g dL or mmol L depending on which unit of measurement you have selected The g dL and mmol L results will always include a decimal point When y
4. 0 F to 86 F mDo nol freeze aKeep away from direct sunlight and heat aDo nol use the test strips after the expiration date sMark the first opening date on the vial The test strips should be used within 2 months after first opening aTightly seal the vial cap immediately after removing a test strip ao nol handle the test strips with wet or dirty hands Warning and Precautions mDo not cut bent scratch or alter the test strip in any way wDiscard each test strip after single use aDo not use the test strips after the expiration date athe test strips should be used within 2 months after first opening Code calibrate the EasyTouch Series Hemoglobin Meter to match the code number printed on the EasyTouch Hemoglobin Test Strips Vial al your blood hemoglobin lest results are not consistent with your expected results and you have followed all instructions described in the EasyTouch Series Monitoring System User s Manual call your healthcare professional mNever make significant changes to your anemia control program or ignore physical symptoms without consulting with your healthcare professional ale sure to follow your local regulation for proper disposal of used test strips and lancets Keep the test strips vial away from children The cap or vial may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation elo not use tincture of iodine to disinfect fingertip
5. EasyTouch Hemoglobin Test Strips For in vitro diagnostic use only Important Please read this information and the EasyTouch Series Hemoglobin Monitoring System User s Manual before using EasyTouch Hemoglobin Test Strips If you have any questions and or need assistance please contact eur authorized distributors in your country Intended Use EasyTouch Hemoglobin Test Strips are designed for in vitro diagnostic use with the EasyTouch Series Hemoglobin Meter for self testing hemoglobin level in fresh capillary whole blood It is suitable for anemia management at home or professional use Summary The EasyTouch Series Hemoglobin Monitoring System is designed for quantitative measurement of hemoglobin level in fresh capillary whole blood This measurement is based on determination of the current changes caused by the reaction of hemoglobin with the reagent on the electrode of the strip When the blood sample gently touches the sample target area of the strip the blood is automatically drawn into the reaction zone of the strip The test result will be displayed on the screen alter 6 seconds Measurement Range The measurement range of the EasyTouch Series Hemoglobin Monitoring System is from 7 to 26 g dL 4 3 mmol L to 16 1 mmol L Reagent Each EasyTouch Hemoglobin Test Strip contains the following regent Hemoglobin catalyst Storage and Handling eStore the test strips at temperature between 4 C to 30 C 4
6. echnology Inc No 188 Jnonghua South Road Sonne Yhunan Township Miaoli County t Taiwan 35057 E mail service bioptik com tw MT Promed Consulting GmbH IEC REP Altenhofstrasse 80 66386 St IngberVHassel Germany Labeling and Information Q Do not reuse Cli Consult instruction for use In vitro diagnostic device 4 Temperature limitation TN Catalog number Batch cod REF Product number bg Used by REP EU Representative se Keep away from sunlight Keep Ory Rev B2 08 11 P N 12020169 CS on
7. ou have any questions or inconsistent test results check the following items then repeat the test 1 Be sure the drop of blood completely filled the reaction zone of the test strips Check if the strips are within the expiration date Check if the code number of the test strips matches the code number displayed on the screen Check meter performance with the check strip Check meter and test strip performance with EasyTouch Control Solutions When test results are still questionable or inconsistent consult your healthcare professional before making any changes to your anemia medication program Caution If your hemoglobin test results are abnormal or you do not feel comfortable with your test results repeat the test with a new test strip If your test result is not consistent with your expectation you should contact your healthcare professional and follow his or her treatment advice The EasyTouch Series Hemoglobin Monitoring System should not be used for the diagnosis of anemia or for the testing of newborns Expected Value The expected hemoglobin value for a normal person is as following Male 13 5 16 5 g dL 8 4 10 2 mmol L Female 12 1 15 1 g dL 7 5 9 4 mmol L The above range is just a reference and it s not suitable for every person Consult your physician for the range appropriate for you y Limitations EasyTouch Hemoglobin Test Strips are designed only for use wilh Fresh Capillary Whole Blood Sam
8. ple ab N DO NOT use serum or plasma samples DO NOT use venous or arterial blood samples sThe system is designed to use at temperature between 57 2 F to 104 F 14 C to 40 C Outside this range the system may yield false results Extremes in humidity may affect the results A relative humidity greater than 85 may cause false results aDo not reuse the test strips ao not use sodium fluoride ot iodoacetic acid as a preservative for blood samples ahiematocrit The test strip results are not significantly affected by hematocrits in the range of 20 to 70 Hematocrit levels less than 20 may cause false high readings while hematocrit levels greater than 70 may cause false low readings If you do not know your hematocrit level consul your healthcare professional wNeonatal EasyTouch Hemoglobin Test Strips used for testing neonatal blood specimens are not validated ulnterferences Blood specimens containing Ascorbic Acid Vitamin C greater than 150mg dL L Dopa greater than 20 mg dL Dopamine greater than 20 mg dL and Methyl Dopa greater than 4 mg dL may give inaccurate hemoglobin results aPatienls undergone oxygen therapy may yield false results sLipaemic samples Cholesterol up to 500 mg dL or triglycerides up to 3000 mg dL do not significantly affect the results Grossly lipaemic p atient samples have not been tesi and are not recornmanded far testing with the EasyTouch Series Hemoglobin Monitoring System athe
9. system is not recommended for use at the altitude of up to 8 000 feet above sea level Test results may be false if the patient is severely dehydrated or severely hypol nsive in shock or in hypoglycemic hyperosmolar State with or without ketosis aCritically ill patients should ng be tested at home using the EasyTouch Series Hemogbin Monitoring System Do not use tincture of iodine to disinfect fingertip Performance Characteristics The performance of the EasyTouch Series Hemoglobin Monitoring System is evaluated both in laboratory and clinical tests This system use Celllaca analyzer as reference 1 Accuracy The specimens ranged from 8 1 g dL to 21 7 g dL 5 02 mmol L to 13 46 mmol L Number of Samples Range g dL 8 1 21 7 0 9761 Slope Intercept g dL 0 5641 0 9667 r2 corr coef 2 Precision The Precision data was obtained in a laboratory study using the EasyTouch Series Hemoglobin Monitoring System to analyze fresh heparinized venous blood sample n 100 per level Average g dL S D g dL Reference 1 Tietz N Fundamentals of Clinical Chemistry 3rd Ed W B Saunders Co Philadelphia PA 1987 P 427 2 Biosensors Microelectrochemical Devices Institute of oe Publishing Bristol Philadephia and New York 1992 3 Burtis C A amp Ashwood E R Clinical Chemistry Third Edition Philadephia W B Saunders Co 1999 P 1815 Manufacturer Control weal Bioptik T
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