OMRON blood glucose test strip HEA-STP30
Contents
1. OMRON blood glucose test strip HEA STP30 For Self Testing Please read this information before using HEA 230 amp HEA 232 system This instruction is helpful to understand the operation process The OMRON blood glucose test strip HEA STP30 should be used with OMRON Blood Glucose meters HEA 230 amp HEA 232 and is intended for blood glucose monitoring by people with diabetes HEA STP30 test strips only need 1uL fresh capillary blood for one testing Blood glucose concentration result will be showed in 5 seconds after you apply a blood sample into the test zone intended use The OMRON blood glucose test strips HEA STP30 are intended to use for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips The OMRON blood glucose test strips HEA STP30 must be used with the OMRON blood glucose Meter HEA 230 amp HEA 232 Testing is done outside the body They are designed for self testing to monitor the effectiveness of diabetes control The device should not be used for screening or diagnosis of diabetes or for testing neonates A Warning 1 OMRON HEA 230 amp 232 system should not be used for screening or diagnosis of diabetes or for testing neonates 2 For in vitro diagnostic use only 3 Do not alter your treatment based on the test result of these systems without instructions from your doctor 4 Read the instruction manual for your meter before use If your have any q2. Accuracy The accuracy of the HEA 232 system was assessed by comparing blood glucose results obtained by patients with those obtained using clinical analyzer The following results were obtained 115 subjects at two clinical centers Number and of results within reference for values were lt 75 mg dL 4 2mmol L Within 5 mg dL 0 3mmol L Within 10 mg dL 0 6mmol L Within 15 mg dL 0 8mmol L 10 32 31 3 26 32 81 3 32 32 100 Number and of results within reference for values were gt 75 mg dL 4 2mmol L Within 5 Within 10 Within 15 Within 20 104 198 52 5 149 198 75 3 177 198 89 4 194 198 98 0 Precision This study shows a variability from strip to strip in sample tests The results are shown in the following table Within Run Precision measured CV 32 9 mg dL 1 8mmol L SD 1 8 mg dL 0 1mmol L 71 9 mg dL 4 0mmol L 2 7 Samples Sample 1 Sample 2 17 1 5 Sample 5 17 Reference 1 Kilpatrick E S Rumley A G and Rumley C N Diabetes Medicine 1995 p 341 2 Burtis C A Ashwood E R eds Tietz Textbook of Clinical Chemistry 2nd Edition Philadelphia W B Saunders 1994 2190 3 Standards of Medical Care in Diabetes 2010 Diabetes Care January 2010 vol 33 no Supplement 1 811 861 2010 ADA al MANUFACTURER CONSULT INSTRUCTIONS FOR USE PAPER RECYCLE T BATCH CODE TEMPERATURE LIMITATION Ec REP AUTHORISED REPRESENTIVE IN THE EUROPEAN C
3. to clean your hands and punch site Massage the fingertip gently will help you obtain a round drop of blood You can choose a different puncture site each time you test to decrease the pain feel Do not squeeze excessively blood volume OMRON blood glucose test strips HEA STP30 just need one micro liter volume for each test A Warning Keep lancet device away from children it is harmful if incorrect use A Please make sure your hand is dried before taking the blood sample Step 4 Apply sample Use the lancing device to obtain a blood sample When the flashing fingertip and blood drop symbol appear on the display apply a drop of blood to the narrow channel in the top edge of blood in window Your blood glucose test result will appear on the display after the meter count down from 5 to 1 elmportant information about HEA 230 amp HEA 232 testing eCheck the confirmation window is full with blood eDo not add more blood to the test strip e The blood sample must be 1 uL in volume e Testing immediately after obtaining a blood sample A Caution Please follow proper precautions in accordance with local regulation A when disposing of all materials The units used in HEA 230 amp HEA 232 glucose meter was set as mg dL or mmol L by the manufacturer Please be aware of what unit your meter is The glucose value can be transferred between these two units by the equation 1 mmol L 18 02 mg dL Test results The unit of HEA 230 amp HE
4. A 232 measure is mg dl mmol L means by different countries Your blood glucose test result will show after the meter count down from 5 to 1 Test range 20 600 mg dL 1 1 33 3 mmol L The meter will appear HI indicating a high glucose level if your test result is higher than 600 mg dL 33 3 mmol L You should repeat your test and if the message appears again call your healthcare professional immediately Expected glucose value Blood glucose management requires the helps of a healthcare professional Together you can set your own range of expected blood glucose values arrange your testing times and discuss the meaning of your blood glucose results Time of day Glucose range for people Your target glucose without diabetes range Fasting and before meals lt 100mg dL 5 6mmol L 2 2 hours after a meal lt 140mg dL 7 8mmol L A Caution The HEA 230 amp HEA 232 meter measurement unit was set as mg dL or mmol L from manufacturer side the unit exchange ratio is as the followings 1 mmol L 18 02 mg dL e LO lt 20 mg dL or HI gt 600 mg dL readings might indicate a potentially serious medical condition Please repeat a test and consult your healthcare professionals if a similar result is achieved again e f test results still do not match how you feel contact your doctor e f your reading is not consistent with your symptoms or if your blood glucose result is less than 70 mg dL 3 9 mmol L or higher th
5. OMMUNITY IVD IN VITRO DIAGNOSTIC MEDICAL DEVICE Sample 3 Sample 4 Council Directive 98 79 EC on in vitro diagnostic medical devices IVD For self testing a KEEP DRY DELBio INC 3F 252 Shangying Road Guishan Industrial Zone Taoyuan County 33341 Taiwan www delbio com tw 0120 Ec rep Deltronics Netherlands BV Zandsteen 15 2132 MZ Hoofddorp The Netherlands 5011554700 12 06 REV 00 2012 6 14 _E F 11 27 03
6. an 180 mg dL 10 0 mmol L you should contact your healthcare professional and follow his or her treatment advice Limitation of procedure HEA STP30 test strips give accurate results when the following limitation is observed e The test strips are for single use only do not reuse the strip e Do not use for the testing of newborn e Use only fresh capillary whole blood e Do not use serum or plasma e Hematocrit is the percentage of red blood cell in blood Extremes in hematocrit may affect test results Hematocrit level less than 30 may cause falsely high reading and hematocrit level greater than 55 may cause falsely low reading e The temperature of test condition is between 10 40 C 50 104 F e The humidity of test condition is below 90 RH e Keep the strip vial away from light and high heat Storage temperature range is between 4 30 C 39 86 F and humidity should be below 75 RH 2012 6 14 _E F 11 27 03 OMRON OMRON blood glucose test strip HEA STP30 For Self Testing Please read this information before using HEA 230 amp HEA 232 system This instruction is helpful to understand the operation process e Do not use the blood sample contained anticoagulation or preservatives e OMRON blood glucose test strips HEA STP30 may be used at altitudes up to 10 000 feet 3048 meters without an effect on test results e Hemolysis may affect test results The effect of hemolysis in a
7. nd control solution Top Edge Apply blood sample here Inserting Bar Insert this test strip port with this side facing up UOUWO j You should prepare following material e HEA 230 or HEA 232 meter e HEA STP30 test strips e Alcohol prep pad e Lancing device e Sterile lancet Please place HEA 230 amp HEA 232 meter control solution and HEA STP30 test strips at room temperature before testing Rapidly temperature change may yield falsely inaccurate results Test procedure of blood glucose meas Step 1 Test strip preparation 5011554700_HEA_STP30 MANUAL indd 1 Take a test strip from the vial To protect test strips from exposure to air please press the cap of the vial till it clicks Insert the test strip contact bars end first and facing up into the test port The meter will turn on and the display will show the most recent test result then symbol of finger tip and blood drop Be sure the meter and the test strip codes match Please refer to the instructions in user manual for more details Step 2 Insert a lancet Please use a new lancet to avoid unexpected contamination before testing Insert the lancet into lancet holder and twist the protective disk until it separated from the lancet Adjust the puncture depth setting to an appropriate depth Slide the ejection cocking control back until it click The lancing device is now ready for use Step 3 Blood sampling Use soap water or alcohol prep pad
8. stem display results between 20 600 mg dL 1 1 33 3 mmol L Accuracy The accuracy of the HEA 230 system was assessed by comparing blood glucose results obtained by patients with those obtained using clinical analyzer The following results were obtained 120 subjects at two clinical centers ACaution The HEA 230 amp HEA 232 meter measurement unit was set as mg dL or mmol L from manufacturer side the unit exchange ratio is as the followings 1 mmol L 18 02 mg dL 40 443 mg dL 2 2 24 6mmollL Number and of results within reference for values were lt 75 mg dL 4 2mmol L Within 5 mg dL 0 3mmol L Within 10 mg dL 0 6mmol L Within 15 mg dL 0 8mmol L 26 40 65 34 40 85 39 40 97 5 Number and of results within reference for values were 75 mg dL 4 2mmol L Within 5 Within 10 Within 15 Within 20 67 200 33 5 135 200 67 5 178 200 89 197 200 98 5 Precision This study shows the variability from strip to strip in sample tests The results are shown in the following table Within Run Precision HEA 232 performance characteristics Traceability The test result of OMRON blood glucose monitoring system HEA 232 is plasma 0011554700_LHEA_STP30 MANUAL indd 2 calibrated by chemistry analyzer and the analyzer was calibrated with a NIST traceable glucose standard solution Measurement range HEA 232 system display results between 20 600 mg dL 1 1 33 3 mmol L
9. uestion contact your distributors How to storage strips e Do not use HEA STP30 strips if the vial is opened or damaged e Write the open date on the vial label when you first open it You should discard your strips by 3 months from first opening the vial e Store HEA STP30 strip vial in a cool dry place Keep away from light and heat e Do not store your HEA STP30 strips in the refrigerator e Store your strips in their original vial only e Do not transfer test strips to any other container e Immediately replace the vial cap after you remove a HEA STP30 test strip A Warning Need to tightly seal the cap of the container provided to protect test strips Checking HEA 230 amp HEA 232 system When to run the glucose control solution test You think your test strips have been damaged Test result com paring with how you feelis not compatible with how you feel 0O You think your glucose meter could be broken A Warning If you will like to perform control solution test or have any question please contact your local authorized distributor for more information The OMRON blood glucose monitoring system HEA 230 amp HEA 232 uses the state of art bioelectrochemistry detecting technology Assure you get an accurate test result Read user guide and strip instruction before using Use control solution to check the HEA 230 amp HEA 232 regularly Well store the HEA 230 amp HEA 232 meter HEA STP30 strips a
10. whole blood sample was reported to interfere the glucose meter measurement e Please contact your healthcare professionals if the result does not consist with the way you feel and please not to change your medication without approval of a healthcare provider e Patients undergoing oxygen therapy may yield falsely low results e f the patient is severely dehydrated in shock or in a hyperosmolar state the test results may be incorrect Limitation of interferences Interfering substances which have been tested Exogenous substances ascorbic acid Vitamin C acetaminophen dopamine gentisic acid Ibuprofen levodopa methyldopa maltose salicylic acid tetracycline tolazamide and tolbutamide Endogenous substances bilirubin creatinine cholesterol triglyceride uric acid urea and glutathione These substances will not cause significant interference in blood glucose measurement when their concentrations are normal in human body or below therapeutic level Reagent composition Each test strip contains Glucose oxidase Aspergillus niger 2 5 Electron shuttle 30 Enzyme stabilizer 5 Other ingredients 60 HEA 230 amp HEA 232 performance che HEA 230 performance characteristics Traceability The test result of OMRON blood glucose monitoring system HEA 230 is plasma calibrated by chemistry analyzer and the analyzer was calibrated with a NIST traceable glucose standard solution Measurement range HEA 230 sy
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