- Suresign Diabetes
Contents
1. Higher than 240 mg dL 13 3 mmol L LIMITATIONS The test strips are used for venous blood or fresh capillary whole blood samples 1 DO NOT use serum or plasma sample 2 DONOT use anticoagulant NaF or potassium oxalate for venous sample preparation 3 DO NOT use neonate blood sample 4 Extreme humidity may affect the results A relative humidity greater than 90 may cause incorrect results 5 Use this system at a temperatures between 50 F and 104 F 10 C and 40 C Outside this range the system may get incorrect results 6 DO NOT reuse the test strips The test strips are for single use only 7 Hematocrit HCT The HCT between 20 and 60 will not significantly affect the results HCT below 20 may cause higher results HCT above 60 may cause lower results If you do not know your HCT level please consult with your doctor 8 Altitude up to 3 048 meters above sea level has no effect on readings Healthcare providers Please note these additional Limitations 1 Ifthe patient has the following conditions the result may be inaccurate Severely dehydrated Severely hypotensive low blood pressure In shock In hypoglycemic hyperosmolar state with or without ketosis 2 Lipemic samples Cholesterol level up to 500 mg dL 12 92 mmol L and triglycerides up to 3 000 mg dL 33 6 mmol L do not affect the results Do not test grossly lipemic patient samples with Suresign Resure SMBG system 3 DO not use2. measured with both venous blood and control solution in the laboratory The results are shown in the table below Blood ay mg dL mmol L 40 2 2 Blood a mg dL mmol L 108 6 0 CV 3 5 Blood a mg dL mmol L 137 7 6 CV 3 3 Blood a mg dL mmol L 223 12 4 CV 3 1 399 22 2 CV 2 8 512 28 4 CV 2 7 42 2 4 SD 2 5 CV 3 2 CV 2 7 SD 2 9 Within Run Blood a mg dL mmol L Blood ay mg dL mmol L Control a mg dL mmol L Control a mg dL mmol L 120 6 7 Control a mg dL mmol L 351 19 5 This shows that Suresign Resure system has good repeatability Total Run ACCURACY STUDY The accuracy of the Suresign Resure Self Monitoring Blood Glucose System was assessed by comparison which was used in laboratories The results below were obtained by 159 subjects with diabetes at three independent clinical sites The regression statistics are derived from a plot of the Suresign Resure capillary data versus YSI plasma data Slope 0 9803 Intercept 0 1646 mmol L 2 9625 mg dL Correlation coefficient 13 6852 Number of subject 159 Range tested 2 64 31 74 mmol L or 47 5 566 5 mg dL R square 0 9782 REFERENCES 1 Cass A E G et al Anal Chem 56 1984 p 667 2 Tietz N Fundamentals of clinical chemistry 3 Ed W B Saunders Co Philadelphia PA 1987 p 427 3 NCCLS document M29 A Protection of the laboratory worker from instrument biohazards and infectious disease transmitted by blood body flui
3. Ce TTC TCC TPCT CCIE TC CE ITT CE TEPC ETE TET CPE e CECT CRE TTC eee PCe Tene Pee Te PCe ene reer TTT E AA A This product meets the requirements of Directive 98 79 EC in vitro diagnostic medical devices wal Manufacturer EPS Bio Technology Corp No 8 R amp D RD Ill Hsinchu Science Park Hsinchu Taiwan 30077 Tel 886 3 6686868 Fax 886 3 6686866 E mail info epsbio com tw Website http www epsbio com EC REP Obelis s a Boulevard G n ral Wahis 53 B 1030 Brussels Belgium Tel 32 2 732 59 54 Fax 32 2 732 60 03 E Mail mail obelis net Distributor CIGA Healthcare Ltd Kilcran House Kildowney Road Ballymena UK BT44 9EY E mail info suresign com Website www suresign com C 0537 IFU RSBGM107 TS RESURE REV 07 14
4. SURESIGN SUIE Instructions Suresign Resure Blood Glucose Test Strips INTENDED USE The Suresign Resure SMBG System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood samples drawn from the fingertips palm or forearm Testing is done outside the body In Vitro diagnostic use It is indicated for self testing by persons with diabetes or in clinical settings by healthcare providers as an aid to monitor the effectiveness of diabetes control The system is not to be used on neonates is not for the diagnosis of or screening for diabetes mellitus and that alternate site testing can only be used during steady state blood glucose conditions IMPORTANT Please read this insert and the Suresign Resure User s Manual before using Suresign Resure Blood Glucose Test Strips If you have any questions and or need assistance please contact our authorized distributors in your country PRINCIPLE Apply a blood sample to the blood collection area at the tip of the strip The test strip will draw the blood sample into the reaction zone The FAD binding glucose dehydrogenase catalyzes the glucose dehydrogenation It will produce gluconolactone During the reaction a mediator transfers electrons to the electrode surface and generates a current The amount of the current is proportional to the amount of glucose present in the blood sample After 5 seconds the Suresign Resure meter will
5. ds and tissue 1997 4 American Diabetes Association Diagnosis and Classification of Diabetes Mellitus m Position Statement Diabetes Care 34 Supp 1 S66 2011 5 American Diabetes Association Standards of medical care in diabetes Table 10 Diabetes care 2011 Vol 34 Suppl 1 S21 LABELING AND INFORMATION BESO EEE EEE EEE EEE EEE EEE EE EE EEE ERECT PRCEEEE EE TERE PETER EE EE TCT EE TE TOLER TE TOLER RE COLTER TEETER TCE EE EE CE EEE EE CEE EE ARARRR NARAR RRN ARAARA NARAR RANAR RR RANAN CUCERE TER CREE ELEC REECE CREE CECT EEE CERT EET IRERE RIERA IRRE AEIR RIAIR ER AEIR EIR R EAER ER EAER EREEREER RER Consult instructions for use IV D _ In vitro diagnostic l medical device l a ATETEA EIE SSTA EEEE EEE ANSEES EAA A EAEE TE ATIII Ure Pee REEDED eee Eee eee eee eeeeeere reece rece erect ty wal Manufacturer CONTROL Control ee ea aa 7 eee eee ere eT ee SN eganumoer EC REP _ the European Community Sufficient for L 6 months until the product em _ expires upon opening Susddddascdenecddedsdiensdacedcccenssduens dveusvueecsceecscedesduaeccsdeedsceveduueeccdececsceucescacecccdecccdeccdecah edacuenuaiadagatssacanaagcnuseduesdudivays C AEE AAA AAA A AIAL AA A acces caucedscedacdeescdddecseneacscaeeceeeeesceeed _ Blood glucose test Blood glucose test result in result in mg dL mmol L E PePeree eee Tere TCR CRE CECE TCR e CRT CTC RET MCT C CETTE P CPE TT EETELETEETCCTTTETTCETTCTECETTCTEC TT Tere CHT eT Ce re TCL
6. ep 4 Thoroughly wash hands with soap and water after performing your glucose testing For detailed information on the test procedure please refer to the User s Manual QUALITY CONTROL It is recommended to run a control solution test whenever you 1 Begin using a new bottle of test strips 2 Question your blood test results 3 Check that the meter and test strips are working properly and that you perform the test correctly at least once 4 Suspect the meter or test strips are working incorrectly 5 Drop the meter 6 Expose the test strips to temperatures outside the storage conditions 36 F to 86 F 2 C to 30 C Use the control solution to check the performance of the meter and test strips Please follow the instructions described in the section Control Solution Test of the User s Manual Use the Suresign Resure Glucose Control Solution to test the system Don t use other manufacturer s control solution Other control solution may provide incorrect results When the results fall within the specified ranges printed on the strip bottle label the system is working properly If your control solution test results are outside the range repeat the control solution test Results that fall outside the range may be caused by 1 Expired or contaminated control solution 2 Error in performing the test 3 Meter malfunction 4 Test strip deterioration DO NOT use the system to test your blood until you
7. fter a meal after taking insulin or during or after exercise 2 AST can only be used during steady state blood glucose conditions AST should only be performed under the following conditions Testing before a meal In a fasting state 2 hours or more after a meal 2 hours or more after insulin dosing 2 hours after physical activity Fingertip test only If sick If blood glucose is low After exercising When you have just taken insulin Two hours or less after eating If you often do not notice when your blood glucose is low After injecting rapid acting insulin 2 hours or less 3 Consult with your healthcare provider before you test palm and forearm TESTING YOUR BLOOD GLUCOSE LEVEL Wash and dry your hands thoroughly Insert the lancet into the lancing device Prepare the lancing device according to the users manual To test your blood glucose level Please follow these steps to test Step 1 Insert Test Strip Take a test strip and replace the bottle cap quickly Insert the test strip into the slot of the meter The meter will turn on Step 2 Apply Sample Follow the sample collection procedures to get a drop of blood While the appears bring your blood to the collection area on the test strip The blood will automatically be drawn into the reaction zone The meter will begin to run Step 3 Accurate Results after 5 seconds Your result will appear on the screen after 5 seconds St
8. get a control solution test result within the specified range TEST RESULTS If LO appears on the screen your blood glucose level is lower than 20 mg dL 1 1 mmol L If HI appears that your blood glucose level is higher than 630 mg dL 35 0 mmol L When you get any questions for the readings check the following items first and then repeat the test If the results are still questionable consult your doctor 1 Ifthe strips are within the expiration date 2 Make sure the drop of blood in the whole reaction zone 3 Check meter and test strip performance with Suresign Resure Glucose Control Solutions Expected Results The Suresign Resure Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab results For Non Diabetic The American Diabetes Association recommends a post meal glucose level of less than 140 mg dL 7 8 mmol L and a pre meal glucose of less than 100 mg dL 5 6 mmol L For Non Pregnant Adults The American Diabetes Association recommends a post meal glucose level of less than 180 mg dL 10 0 mmol L and a pre meal glucose of 70 130 mg dL 3 9 7 2 mmol L CAUTION Any low or high blood glucose readings can indicate a potentially serious medical condition If the readings do not reflect your symptoms repeat the test with a new test strip Contact your doctor when your reading is A Not consistent with your symptoms B Less than 60 mg dL 3 3 mmol L C
9. home use blood glucose meters to test critically ill patients 4 DO NOT use during xylose absorption testing Xylose in the blood will interfere Self Monitoring Blood Glucose System 5 Interfering Substances depend on the concentration The below substances up to the test concentration will not affect the readings Concentrations 5E Level of the interference tested ee Ascorbic Acid 4 mg dL 0 26mmol L lbuprofen 50 mg dL 2 43mmol L L Dopa 1 8 mg dL 0 09mmol L Sodium Salicylate 50 mg dL 3 12mmol L Tetracycline 1 5 mg dL 0 03mmol L 5 32 3 81 3 20 Tolbutamide 100 mg dL 3 7mmol L 2 60 12 30 0 89 Bilirubin unconjugated 2 4 mg dL 0 04mmol L 2 52 4 05 0 23 175 4 44 80 mg dL 4 4 mmol L 250 mg dL 13 9 mmol L 500 mg dL 27 8 mmol L Uric acid 8 mg dL 0 48mmol L 1 75 Xylose 4 mg dL 0 27mmol L 4 44 Use the anticoagulant EDTA or sodium Heparin or Lithium Heparin to preserve the venous blood and capillary blood specimens would not affect the readings of Suresign Resure SMBG System If the specimen was preserved by the anticoagulant NaF potassium Oxalate contained sodium fluoride the reading of Suresign Resure SMBG System would be seriously interfered PERFORMANCE CHARACTERISTICS The test range is between 20 to 630 mg dL 1 1 35 0 mmol L Validate the test strips performance in both laboratory and clinical tests PRECISION Precision of the Suresign Resure Self Monitoring Blood Glucose System was
10. ntrol program without consulting your doctor 8 The system should be used at a temperature between 10 C and 40 C 50 F and 104 F Outside this range the system may get incorrect results eee IPN IMPORTANT If the control solution test results are outside the range your meter and test strip may not be working as a system Follow the correct procedures and repeat the control solution test Make sure the control solution is clean without contamination e g Turbid Do not use the meter until test results fall within the appropriate range If the problem continues please contact your health professional SUPPLIES FOR TESTING YOUR BLOOD GLUCOSE Suresign Resure Blood Glucose Meter Suresign Resure Blood Glucose Test Strip Lancing Device Lancets User s Manual gt o o SAMPLE COLLECTION AND PREPARATION This system is for use in fresh capillary blood The blood sample must be used right away The sample volume requires at least 0 6 micro liters To obtain a drop of blood follow these steps Step 1 Wash and dry your hands thoroughly Step 2 Prepare the meter according to the user s manual Step 3 If you use an alcohol swab Make sure that your finger is entirely dry before lancing Step 4 Puncture and get a drop of blood Avoid pressing too hard against the punctured site ALTERNATIVE SITE TESTING AST 1 AST results may differ from fingertip results when glucose levels are changing rapidly e g a
11. show glucose concentration on the screen REAGENT COMPOSITION Each test strip contains the following reagent 6 w w FAD glucose dehydrogenase Aspergillus sp 2 0 IU test strip Potassium ferricyanide Non reactive ingredients 56 w w 38 w w STORAGE AND HANDLING 1 Store the test strip package in a cool dry place between 2 C 30 C 36 F 86 F Do Not freeze Keep out of direct sunlight and heat Write the date on the bottle when first opened Discard test strips 6 months after first opening date Replace the cap quickly after taking the test strip from the bottle Handle the test strip only with dry and clean hands Store your test strips in their original bottle only Do not move them to any other bottle or container WARNINGS AND PRECAUTIONS For in vitro diagnostic use only Do not swallow Do not use the test strip after the expiration date Do not re use test strips Do not cut bend scratch or alter the test strip in any way Warning for potential biohazard This warning is for the healthcare providers who use this system on multiple patients They should know the product comes in contact with human blood After cleaning dispose of the product properly as if avoid transmitting viral disease 6 If the readings are not consistent to your symptoms check the manual first Make sure you have followed all instructions and then contact your doctor 7 Never make any changes to your diabetes co
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