03-RN01-UM-01H BK使用手冊(英文)(外框檔)-cover
Contents
1. 2 Lo 1 Blood glucose level is 1 lower than 20 mg dL 2 Test strip has problem 2 34 Solution Review the instructions and try again with a new test strip Check the test strip vial to make sure that it is not marked beyond the expiration date Review the instructions and try again with a new test strip Check the test strip vial to make sure that it is not marked beyond the expiration date Chapter 9 Specifications System Accuracy Test Sample Measuring Time Measuring Range Sample Volume Strip Storage Condition Operation Temperature Relative Humidity Memory Battery Type Battery Life Dimensions Weight 20 at glucose level gt 75 mg dL Capillary whole blood Less than 10 seconds 20 600 mg dL 1 1 33 3 mmol L About 1 1 5 uL 10 30 C 10 40 C Less than 95 180 test results One 3V CR2032 lithium battery Approximately 1 000 tests 61 77 19 mm About 47g batteries not included 35 36 Chapter 10 Limitations Please observe the following limitations for obtaining accurate results of BeneCheck Blood Glucose Monitoring System I For In vitro diagnostic use only External use only Do not dispose test strips in high humidity or direct sunlight Don t freeze the strips BeneCheck Blood Glucose Test Strip is for single use only please do not reuse the test strip Handle the strip with clean and dry hands lancing site for the test shou2. 29 30 Chapter 6 Storage and Handling of Meter and Strips Due to sensitive to heat and humidity the performance of test strips may be affected by improper storage and handling Please store the test strips and meter carefully according to the specifications listed in Chapter 9 Note 1 Store the meter code strip test strips and control solution at room temperature Do not expose them beyond the range described in Chapter 9 2 Do not freeze or refrigerate the meter and strips 3 Keep the meter clean by wiping the exterior of the meter with a tissue or lint free cloth Chapter 7 Icon and Alert Tones 7 1 Icon on the Screen The vivid and clear information icons on the screen are helpful Strip Loading Icon and convenient In addition ra to providing accurate blood Result Area G Blood Loading Icon glucose test results the NI H sN Wu Code Number Icon Memory Number Icon icon design on the screen are easy to understand at a glance Battery Icon and will save you the effort of carrying the User s Manual for reference System Check Icon Temperature Icon af D gt 3 lt ee ao 7 2 Alert Tones e Normal Alert Sound a short beep e Warning Alert Sound 5 short beeps e Turning On Off Alert Sound along beep Average Icon Unit Icon 31 32 Chapter 8 Error Message and Trouble Shooting Message E 0 E 9 E A E b Cause There
3. PD F004 BeneCheck Glucose Control Solution 1 PP E003 BeneCheck Blood Glucose User s Manual 1 PP E006 BeneCheck Blood Glucose Test Strip Instruction 1 al 1 1 1 3 Labelling and Informations Lo NA Operation 40 C 10 C Storage 4 10 C CE 0197 sall Do not re use Keep dry Keep away from sunlight Operation temperature limitation Storage temperature limitation CE certification Manufactured by IVD LOT Use by Read instructions Caution consult accompanying documents EU Representative Catalogue number Product number In vitro diagnostic Lot number 1 4 System Components Meter Front Side BeneCheck Test Port Where you insert the test strip for test LCD Screen for display of operating information and test results Front Button for on off and memory mode operation Meter Back Side Test Strip Battery Cover Lid Electronic Contact Bars Lift upward while replacing Battery Cover Insert this end of the test strip into the the battery For covering the battery Test Port of the meter to activate it BeneCheck Reset Button fs For setup and reset of Screw For holding the meter together do not open or the meter disassemble the BeneCheck Blood Glucose meter Sample Inlet Tag The inlet where the whole blood or control Battery Display information about solution is drawn in When a blood sample 3V lithi
4. a test strip is inserted please be sure to check the code number appearing on the screen is the same as the code number marked on the test strip vial Directions Check the code number on the code strip is the same as the code number on the test strip vial 13 14 Insert code strip into the test port of the meter Wait for the code number to appear on the screen Make sure the code number on the screen is the same as the code number on the code strip Remove the code strip should appear on the screen indicating that the meter has been coded Cautions If E C appears on the screen after removing the code strip there may be a problem with the code strip Perform the coding again and if E C continues to appear please contact the original dealer or supplier for service 2 4 Control Test A control solution is used to check the performance of the BeneCheck Blood Glucose Monitoring System including BeneCheck Blood Glucose Meter BeneCheck Blood Glucose Test Strip and the user s operating skill The system performs adequately if the control test result falls within the indicated control range listed on the test strip vial The system should be checked e When you get the meter for the first time or begin using a new vial of test strip e When you suspect that the meter or the test strips are not working properly 15 e Any time the blood glucose test results are not consistent with how yo
5. may be a problem with the meter or code strip The test strip may be removed after applying blood to the absorbent hole There is a problem with the meter The power of the battery is too low to run a test Solution Repeat the test with a new code strip If the problem persists please contact the dealer for service Review the instructions and try again with a new test strip If the problem persists please contact the dealer for service Review the instructions and try again with a new test strip If the problem persists please contact the dealer for service Replace the battery at once Message E C E t amp Tm Sign EU Cause Usage of the code strip was inserted improperly damaged or incorrect The temperature was below or above the system operating range It could be caused by a used test strip or a temporary or permanent electronic problem Solution Check that the code number on the meter display matches the code number on the test strip vial Code the meter or retest as necessary If the error message appears again please contact the dealer for service Repeat the test after the meter and the test strip have reached the temperature within the operating range Repeat the test with a new test strip If the error message appears again please contact the dealer for service 33 Message Cause Hi 1 Blood glucose level is 1 higher than 600 mg dL 2 Test strip has problem
6. en Always use new test strips e f the wrong end of the test strip is inserted or if the test Strip is inserted backwards the Meter will not activate Insert the BeneCheck Blood Glucose Test Strip and take a blood sample according to the instructions for lancing device in the system Touch the sample inlet of the test strip to the drop of blood sample until the meter sounds a beep that means the Warning J A N e Lancet cannot be reused sample is drawn into the strip successfully e Please always use certified lancets to ensure safety The screen will display a countdown from 10 seconds After 10 seconds the screen will display the glucose results 24 Note e Please complete the test procedures within 3 minutes or the meter will automatically turn off e Do not apply the blood sample on the test strip anywhere other than the sample inlet e Do not apply the blood sample to a same test strip twice it will cause inaccurate test results 3 3 Care after the Test Directions 1 Follow the instructions for lancing device to treat and discard the used disposable lancet into an appropriate sharps or biohazard container 2 After performing a test remove the test strip and meter will automatically turned off 3 Record the test result and date in your personal diabetes diary Note e Please check your system performance regularly or when you suspect your test result is inaccurate e Dropping bumping or oth
7. er violent impact may damage the meter or cause malfunction e Do not use the meter in an environment with possible magnetic electromagnetic and radioactive interferences Warning e Do not disassemble the meter for any reason e Please follows local regulations to discard used test strips and lancets e Used test strips lancets and any other materials which have been in contact with blood should be treated as potential biohazards If a user has an infectious disease the used test strips and other materials could be sources of infection 25 26 Chapter 4 Meter Memory Function The BeneCheck Meter automatically stores up to 180 records both blood glucose test results and control test results each time a test is performed It also provides you with 7 14 21 and 28 day averages of the blood glucose test results The memory counts up from MO1 through M180 Please follow these directions to recall stored test results Directions 1 Make sure that no test strip is inserted in the meter 2 Press the Front Button once to turn the meter on A full display will appear on screen after a short beep sound 3 Press the Front Button once again before the code number appears The 7 day average 7 DAY A will display on the screen 4 Followed by 14 21 and 28 day average when press the Front Button repeatedly 5 After the 28 average the latest stored result MO1 appears on the screen The memory n
8. es 24 25 Meter Memory PUNCH OMssiisics ci areacimonronseanasend aG ganas 26 27 How to Set the Blood Glucose Measurement Units 28 29 Storage and Handling of Meter and StripS cccceeeeeen ees 30 keom and Alert TONES carain r ARN 31 Error Message and Trouble SOONG isirenisrarriiisiiicsia 32 34 Soe eI E E E E E A T E EE T 35 MEQUON S casein sade haar AAA 36 37 Chapter 1 BeneCheck Blood Glucose Monitoring System 1 1 Introduction Thank you for choosing BeneCheck Blood Glucose Monitoring System The BeneCheck Blood Glucose Monitoring System is designed by General Life Biotechnology Co Ltd and marketed all over the world The BeneCheck Blood Glucose Monitoring System provides you with accurate plasma calibrated results based on electrochemical sensor technology and the superior capillary sampling The BeneCheck Blood Glucose Monitoring System requires only a small amount of blood the blood glucose level is precisely calculated and displayed in 10 seconds Intended Use The BeneCheck Blood Glucose Monitoring System is designed to measure the blood glucose levels in whole blood The test strips are for testing outside the body in vitro diagnostic use It should be used only for testing blood glucose with fresh capillary whole blood samples The system is suitable for diabetics to monitoring their blood glucose at home by themselves and also can be used at clinical sites by healthcare professionals to test the blood glucose
9. ial If the test results fall outside the control range please refer to Chapter 8 for trouble shooting 19 20 Chapter 3 How to perform a Blood Glucose Test 3 1 Before Testing Please follow the step by step instructions to ensure accurate test results Materials required to perform a blood glucose test include e BeneCheck Blood Glucose Meter e BeneCheck Blood Glucose Test Strip e Lancing Device Lancet e Tissue or cotton ball with 75 ethanol for wiping blood sampling area after test or simply wash hands with soap and water thoroughly before and after test for disinfection Directions Take a test strip and immediately cover the vial to keep the other test strips in dry condition Fully insert the contact bar of the test strip into the test port 2 of the meter The meter will turn on automatically After CH and EL appear on the screen the code 3 number will follow Check the code number on the screen is the same as the 4 one on the test strip vial If not remove the test strip and recode the meter 21 Note 3 2 Perform the Blood Glucose Test e The blood glucose test must be performed within 3 minutes otherwise Directions the meter will be turned off automatically If turned off remove and re insert the test strip to do the test again e Test strips cannot be reused If a used test strip is inserted a warning 1 message E U will display on the scre
10. ld be cleaned and dried thoroughly Do not perform the test while a cell phone is used beside prevent the electronic signal interference Oxygen concentration low in air may cause the test inaccurate there is no effect from altitude up to 10 000 feet above sea level Medical therapy for intravenous injection such as immunoglobulin preparations and peritoneal dialysis solutions containing sugar compounds may cause higher test results Hematocrit Hct range from 30 55 is acceptable Hct less than 30 may cause elevated results Hct above 55 may cause reduced glucose results versus a whole blood reference 37
11. levels of patients The BeneCheck Blood Glucose Monitoring System is calibrated by J amp J DT60 Analyzer Kodak EKTACHEM DT60 Analyzer using venous plasma The DT60 Analyzer is calibrated by VITROS DT calibrators which were referenced to NIST SRM917b and AACC CDC Hexokinase G6PDH Please read the entire USER S MANUAL carefully before using the BeneCheck Blood Glucose Monitoring System to test your blood glucose levels This USER S MANUAL guides you through the operation procedures with illustrated directions and help you find the required informations WARNING Please carefully read the instructions in this USER S MANUAL and become familiar with the test procedures before using the system to test blood glucose level User should do the quality check and consult with a diabetic healthcare professional before doing any important medical decision 1 2 Contents of the Kit Please check the whole package for the BeneCheck Blood Glucose Monitoring System The system includes the following items PD A019 Kit Carrying Bag PD A015 Lancing Device PD A018 Lancets pack Manufacturer For detail information please refer to inside package Optional not included in the standard kit package please contact your local distiubutor for ordering BeneCheck Blood Glucose Test Strip BK G S001 Item No Description Quantity PD A016 BeneCheck Blood Glucose Meter 1 PD A041 BeneCheck Blood Glucose Test Strip vial 1 PD A020 Code Strip 1
12. on again then the meter enters into month setting Set the Month 1 Press and release the front button until the correct month appears 2 Press the setting button and the day segment will start blinking Set the Day 1 Press and release the front button until the correct day appears 2 Press the setting button and hour segment starts blinking Set the Hour 1 Press and release the front button until the correct hour appears 2 Press the setting button and minute segment start blinking 11 12 ud L m Note 3 18 BoB mg dL 9 18 8 08 mg d 9 18 8 08 Set the Minute 1 Press and release the front button until the correct minute appears 2 Press the setting button and temperature unit C or F starts blinking Set the Unit of Temperature 1 Press and release the front button to select the unit of temperature C or F 2 Press the setting button when the desired unit is selected The meter thus completes the setting and turns off automatically Please refer to Chapter 5 for the blood glucose measurement units setting procedure 2 3 Coding the Meter The BeneCheck Blood Glucose Meter should be coded before testing with BeneCheck Glucose Test Strips for the first time or every time a new box of BeneCheck Glucose Test Strips is used Each vial of test strips has an assigned code number The code strip is packaged with the test strip in order to calibrate code the meter Every time
13. u feel or any time you think your results are not accurate e Any time you drop or bump the meter Upon the advice of the healthcare professional Directions a a Insert a test strip and immediately cover the vial to keep I the other test strips in dry condition The meter will turn on automatically After CH and L S appear on the screen the 2 ambient temperature and code number will follow Be careful to make sure the code number is the same as the code number marked on test strip vial 16 A blood drop symbol blinking on the screen means 3 the system is ready for sample loading Please shake well and discard the first three drops of control 4 solution then drop some control solution onto a clean surface Touch the sample inlet of the test strip to the drop of control 5 solution until the meter sounds a beep The screen will display a countdown from 10 seconds 17 18 After 10 seconds the screen will display the control test results Compare the results to the control range listed on the test strip vial Note Do not reuse the test strips Newly opened vial of control solution and test strips must be marked with the opening date e Close the test strip vial lid tightly after use e Do not use BeneCheck Blood Glucose Monitoring System to do any test until you can get the control test result falls within the range listed on the test strip v
14. um battery CR2032 the meter or control solution touches this end the sample will be sucked into the reaction zone automatically Code Strip Front View Chapter 2 Setting up the Meter 2 1 Installing Replacing the Batteries A 3 volt lithium battery CR2032 is included in the meter package Use only Contact Bar 3V lithium batteries Do not use or replace the battery with different types of Insert this end into batteries Doing so will damage the electronics of the meter the Test Port of the meter Instructions 1 Hold the meter with one hand slightly lift the back cover lid i to open the back cover Code Number Tset Mode be Insert a new battery in the meter with the side facing 2 up you will hear a beep sound which indicates that meter Tset Mode G Glucose is on 10 Please back the cover onto the meter 2 2 Set the Year Month Day Hour Minute Temperature unit After a battery is installed in the meter for the first time as described in 2 1 the meter goes into setting mode automatically The directions to setting mode Open the battery cover on the back of the meter press the setting button then a number such 08 will blink on screen which means Year 9 20 9 18 BAB Set the Year 1 Press the front button to advance one year until you get a correct year number 2 After you set the desired year number press the back setting butt
15. umber increases progressively each time the button is pressed till M180 6 To turn the meter off press the Front Button for over 3 seconds and the meter will make a long beep sound The meter will also automaticallyshut down after 3 minutes Note e Please complete the test procedures within 3 minutes or the meter will automatically turn off e Do not apply the blood sample on the test strip anywhere other than the sample inlet e Do not apply the blood sample to a same test strip twice it will cause inaccurate test results 27 28 Chapter 5 How to Set the Glucose Measurement Units Directions 1 Make sure that no test strip is inserted in the meter 2 Open the battery cover of the meter press Setting Button once then a blinking number Ox will appear on Screen See Fig 1 3 3 Press Setting Button repeatedly until the glucose unit mg dL or mmol L blinks on the Screen Press Front Button will switch between mg dL and mmol L See Fig 4a amp 4b 4 Press the setting button once will shift to temperature setting Press Setting Button again will finish the setting and turns off automatically Note e The setting items of the meter is listed as follows Please be careful to set the desired glucose unit Glucose Unit mg dL mmol L Temperature Year Month gt Day gt Hour gt Minute M on pe C F eter OFF lt d
16. wll Manufactu rer GENERAL LIFE BIOTECHNOLOGY CO LTD 5F No 240 Shinshu Road Shin Juang City Taipei 242 Taiwan Tel 886 2 22053698 Fax 886 2 22080779 E mail service glbiotech com tw Website www glbiotech com tw www BeneCheck com tw EU Representative VadeS Administraties Laan van Poot 146 2566ED Den Haag The Netherlands C o197 PP E003 Doc No 03 RNO1 UM 01H Jul 2010 BeneCheck Blood Glucose Monitoring System User s Manual TABLE OF CONTENTS Chapter 1 1 1 1 2 1 3 1 4 Chapter 2 2 1 2 2 2 3 2 4 BeneCheck Blood Glucose Monitoring System KAIRE eO IIi e p oIan AAAI IEN ETIS A NETANE 1 2 Contents of th KiE sareni AT 3 Labelling and INFOFMALIONS A cscs cscs esesssesessssesssnsenssteessnsenssesensneenss 4 System Components Metr aee E E T Test Strips Code Strip Setting up the Meter Installing Replacing the Batteries Set the Year Month Day Hour Set the Minute Unit of Temperature E acta 12 Coding the M teP a ccccecssessssssesssssssssecssssessssecssssessssecssssessssecsssseessssesssses 13 15 Control MOS Urmana tovraasriini ne E O 15 19 Chapter 3 3 1 3 2 3 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 How to Perform a Blood Glucose Test Before Testing sesssesrsssesessssresrsss Perform the Blood Glucose Test Care after the TeSt cc ccssssesssssssessssssssssstsecsssncesssseesecsssecessnteesssnnsssee
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