Untitled - BeneCheck
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1. 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 AN 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 26 Chapter 4 Meter Memory Function The BeneCheck CHOL GLU Meter automatically stores up to 410 records which includes 50 total cholesterol 360 blood glucose test results or control test results each time a test is performed The memory counts up from MO1 through M50 or M360 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 after the code number appears The latest stored result MO1 appears on the screen The memory number increases progressively each time the button is pressed till M50 total cholesterol mode for and M360 for blood glucose mode 4 Press and hold the Front Button will appear the stored memory continuously 5 To turn the meter off press the Setting Button of back side2. sample A beep sound that means the sample is drawn into the strip successfully The screen will display a countdown then display the test results after the countdown 23 3 3 Perform the Blood Glucose Test 1 Insert the BeneCheck Glucose Test Strip and take a blood sample according to the instructions for lancing device in the system 2 Touch the sample Inlet of the strip to the drop of blood sample until the meter sounds a beep which means the sample has drawn into strip successfully 3 The screen will display a countdown After few seconds the screen will display the blood glucose results 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 4 Care after the Test Directions 1 Follow the instructions for lancing device to treat and discard the used 24 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 record diary Note e Please check your system performance regularly or when you suspect your test result is inaccurate e Dropping bumping or other violent impact may damage the meter or cause malfunction
3. 19 mm About 47g batteries not included 33 34 Chapter 9 Limitations 1 For In vitro diagnostic use only External use only 2 BeneCheck Test Strip is designed for one time use only Do not reuse 3 Do not perform the test while a mobile phone is used beside prevent the electronic signal interference 9 1 Limitations of Total Cholesterol Test BeneCheck Total Cholesterol Test Strips give accurate results when the following limitations are observed e Hematocrit Hct percentage may affect test result If Hct levels less than 35 may cause incorrect high measurement results and Hct levels greater than 50 may cause incorrect low measurement results Please consult your medical professionals if you do not know your Hct level e Use only fresh capillary finger whole blood Do not use serum or plasma e BeneCheck Total Cholesterol Test Strips may be used at altitude up to 8 000 feet without an effect on test results Additional Information for Healthcare Professionals e Interferences Acetaminophen uric acid ascorbic acid dopamine gentistic acid ibuprofen methyl DOPA salicylate when at physiological or therapeutical levels do not significantly affect the results Hemoglobin at physiological levels lt 10 mg dL e In situations of decreased peripheral blood flow examples would include but are not limited to severe dehydration in shock or in a hyperosmolar state with or without ketosis hypertension the test
4. for over 5 seconds and the meter will make a long beep sound The meter will also automatically shut down after 1 minutes Note e The day average function can be applied to glucose test mode only Total cholesterol test mode do not have the average funation 27 28 Chapter 5 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 8 Note 1 Store the meter code strip test strips and control solution at room temperature 10 30 C 50 86 F Do not expose them beyond the range described in Chapter 8 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 6 Icon and Alert Tones 6 1 Icon on the Screen Code Number Icon Memory Number Icon The vivid and clear information icons on the screen are _ icon helpful and convenient In Cy Blood Loading Icon addition to providing accurate Result a aan total cholesterol and glucose test results the icones design on a ne the screen are easy to Battery Icon eq Hie mg gL understand at a glance and MAO NG will save you the effort of aN PERS carrying the User s Manual Temperature we for reference DAY Average Icon Unit Icon 6 2 Alert Tones
5. results may be falsely low e BeneCheck Total Cholesterol Test Strips are plasma calibrated tests with serum or plasma sample will give falsely high results e Lipemic samples Glucose levels up to 476 mg dL 13 89 mmoL L do not affect the results Triglycerides and grossly lipemic patient sample have not been tested and are not recommanded for testing with the BeneCheck Total Cholesterol Test Stirps 35 36 9 2 Limitations of Glucose Test BeneCheck Glucose Test Strips give accurate results when the following limitations are observed e Hematocrit Hct percentage may affect test result If Hct levels less than 30 may cause incorrect high measurement results and Hct levels greater than 55 may cause incorrect low measurement results Please consult your medical professionals if you do not know your Hct level e The test strips react with only D glucose and do not react with other sugars which may be present in blood e Use only fresh capillary finger whole blood Do not use serum or plasma e BeneCheck Glucose Test Strips may be used at altitude up to 10 000 feet without an effect on test results Additional Information for Healthcare Professionals e When venous whole blood is used for the test it can be collected into heparin containing test tubes winthin 30 minutes after drawing The results may be 7 lower than a capillary sample Interferences Acetaminophen uric acid ascorbic acid dopamine gentistic acid i
6. E O 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 CHOL GLU Dual Monitoring System including BeneCheck CHOL GLU Meter BeneCheck 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 e Any time the total cholesterol or blood glucose test results are not consistent with how you feel or any time you think your results are not accurate Any time you drop or bump the meter Upon the advice of the healthcare professional Directions Insert a test strip and immediately cover the vial to keep 1 the other test strips in dry condition The meter will turn on automatically After CH and L_ appear on the screen the code 2 number will follow Be careful to make sure the code number is the same as the code number marked on test strip vial Ww BeneCheck 3 A blood drop symbol blinking on the screen means 94 i0 the system is ready for sample loading Tou aa g ga 18 Please shake well and discard the first three drops of control soluti
7. buprofen methyl DOPA salicylate tetracycline tolazamide tolbutamide when at physiological or therapeutical levels do not significantly affect the results Patients undergoing oxygen therapy may yield falsely low results In situations of decreased peripheral blood flow examples would include but are not limited to severe dehydration in shock or in a hyperosmolar state with or without ketosis hypertension the test results may be falsely low BeneCheck Glucose Test Strips are plasma calibrated testing with serum or plasma sample will give falsely high results Lipemic samples Cholesterol levels up to 400 mg dL 10 35 mmoL L and triglycerides up to 3000 mg dL 34 88 mmoL L do not affect the results 37 38 Grossly lipemic patient samples have not been tested and are not recommended for testing with the BeneCheck Glucose Test Strips e Critically ill patients should not be tested with blood glucose meters
8. cets Manufacturer refer to the label on the package 1 3 Labelling and Informations 17 _ om N Operation 40 C 10 C Storage 4 10 C CE 0197 coal a L Do not re use Keep dry Keep away from sunlight Operation temperature limitation Storage temperature limitation CE certification Manufacturer a gD l 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 Test Port Where you insert the test strip for test BeneCheck LCD Screen for display of operating information and test results Front Button for on and memory mode operation Meter Back Side Battery Cover Lid Lift upward while replacing Battery Cover the battery For covering the battery Screw Setting Button For setup and reset of the meter For holding the meter together do not open or disassemble the BeneCheck CHOL GLU Meter Tag Display information about the meter Battery 3V lithium battery CR2032 Test Strip Total Cholesterol Strip Reaction Zone Reaction zone of Total Cholesterol Electronic Contact Bar Insert Electronic Contact Bar of the test strip into the Test Port of the meter to activate it Sample Inlet The inlet where the whole blood or control solution is drawn in W
9. e Normal Alert Sound a short beep e Warning Alert Sound 3 short beeps e Turning On Off Alert Sound a long beep 29 30 Chapter 7 Error Message and Trouble Shooting Message E 0 E 9 E A Cause There may be a problem with the meter or code strip The test may be interrupted after applying blood to the strip There is a problem with the meter Solution Reload the code strip or repeat the test with a new test strip If the problem persists please call your local authorized supplier for service Please don t remove the strip before the test is completed Review the instructions and try again with a new test strip If the problem persists please call local authorized distributor for service Message E b E 1 E t amp T Icon E U Cause The power of the battery is too low to run a test Incompatible code strip with the meter 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 Replace the battery at once Reload the code strip If the problem persists please contact your local supplier 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 31 32 Messa
10. ge Hi Lo Cause 1 Total cholesterol level is higher than 400 mg dL or 10 35 mmol L or blood glucose level is higher than 600 mg dL or 33 3 mmol L 2 A potential problem with the test strip 1 Total cholesterol level is lower than 100 mg dL or 2 59 mmol L or blood glucose level is lower than 18 mg dL or 1 0 mmol L 2 A potential problem with the test strip Solution 1 Review the instructions and try again with a new test strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date 1 Review the instructions and try again with a new test strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date Chapter 8 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 Total Cholesterol gt 150 mg dL 20 at Glucose level gt 75 mg dL 4 17mmol L Capillary whole blood 26 seconds Total Cholesterol lt 10 seconds Glucose Total Cholesterol 100 400 mg dL 2 59 10 35 mmol L Glucose 18 600 mg dL 1 0 33 3 mmol L 2 10 uL Total Cholesterol 0 7 uL Glucose 10 30 C 10 40 C Less than 95 410 test results 50 for Total Cholesterol 360 for Glucose 3V CR2032 lithium battery x 1 Approximately 1 000 tests 61 77
11. hen a blood sample or control solution touches this end the sample will be sucked into the reaction zone automatically The reaction zone of total cholesterol strip has to be filled up with control solution or a blood sample at least 10 uL is essential Glucose Strip Electronic Contact Bars Insert this end of the test strip into the test Port of the meter to activate it BeneCheck Sample Inlet The inlet where the whole blood or control solution is drawn in When a blood sample or control solution touches this end the sample will be sucked into the reaction zone automatically Code Strip Front View Contact Bar Insert this end into the Test Port of the meter Z Gyo 917 SZ Code Number Test Mode Test Mode CHOL Total Cholesterol GLUC Glucose 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 3V lithium batteries Do not use or replace the battery with different types of batteries Doing so will damage the electronics of the meter Instructions Hold the meter with one hand slightly lift the back cover lid to open the back cover Insert a new battery in the meter with the side facing 2 up you will hear a beep sound which indicates that meter is on 10 Place back the cover onto the meter 2 2 Set the Yea
12. o monitoring their total cholesterol or blood glucose at home by themselves and also can be used at clinical sites by healthcare professionals The BeneCheck CHOL GLU Dual Monitoring System is calibrated using venous plasma with calibrators which were referenced to the following standards and method Test Standard Method Total Cholesterol NIST SRM911ib Abell kendall Glucose NIST SRM965 ID MS Please read the entire USER S MANUAL carefully before using the BeneCheck CHOL GLU Dual Monitoring System to test total cholesterol and 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 total cholesterol and blood glucose levels User should consult with a healthcare professional before going ahead important medical decision 1 2 Contents of the Kit Please check the whole package for the BeneCheck CHOL GLU Dual Monitoring System The system includes the following items BeneCheck CHOL GLU Meter BeneCheck CHOL GLU User s Manual Kit Carrying Bag Optional BeneCheck Total Cholesterol Test Strip vial BeneCheck Glucose Test Strip vial BeneCheck Total Cholesterol Test Strip Instruction BeneCheck Glucose Test Strip Instruction BeneCheck Glucose Control Solution Lancing Device Lan
13. olesterol Testing procedures for Blood GIUCOSE eecssecssstssssessssessssteceseeesseeess Care after the TOS bac cessissassics seas nei covsseeravnadvnvenveces oncseannane i i Meter Memory FURCHOM si ccisasctes cine nnna 26 27 Storage and Handling of Meter and StripS ccccceeaeeeeees 28 Icon and Alert TONGS ccciccciceccsinsccatiaazeieraneetcacedactanss agne tes 29 Error Message and Trouble Shooting cseeeeeeeeees 30 32 SPeCCIMCAL ONS iiveds seneacn r Ea E EEE 33 LIME AU ONS seeni dntendedanceensceds steenatieds don trmuesewas cemed sen 34 38 Chapter 1 BeneCheck CHOL GLU Dual Monitoring System 1 1 Introduction Thank you for choosing BeneCheck CHOL GLU Dual Monitoring System The BeneCheck CHOL GLU Dual Monitoring System is designed by General Life Biotechnology Co Ltd and marketed all over the world The BeneCheck CHOL GLU Dual Monitoring System provides you with accurate plasma calibrated results based on electrochemical sensor technology The blood total cholesterol or blood glucose level is precisely calculated and displayed in a short time Intended Use The BeneCheck CHOL GLU Dual Monitoring System is designed to measure blood total cholesterol or blood glucose level in whole blood The test strips are for self testing outside the body in vitro diagnostic use It should be used only for testing total cholesterol or blood glucose with fresh capillary finger blood samples The system is suitable for users t
14. on then drop some control solution onto a clean surface Touch the sample inlet of the total cholesterol or glucose test strip to the drop of control solution until the meter sounds a peep The screen will display a countdown xThe reaction zone of total cholestrol has to be filled up control solution After count down and the screen will display the control test results Compare the results to the control range listed on the test strip vial Note e Do not reuse test strips e Newly opened vials of control solution and test strips must be marked with the opening date e Close the test strip vial cap immediately after taking out the strip Do not use BeneCheck CHOL GLU Dual Monitoring System to do any test until you can get the control test result falls within the range listed on the test strip vial e If the test results fall outside the control range please refer to Chapter 7 for trouble shooting 19 20 Chapter 3 How to perform a Test 3 1 Before Testing Please follow the step by step instructions to ensure accurate test results Materials required to perform a total cholesterol or blood glucose test include BeneCheck CHOL GLU Meter BeneCheck Total Cholesterol or Glucose Test Strip Lancing Device Lancet Tissue or cotton ball with 75 ethanol for wiping blood sampling area before test or simply wash hands with soap and water thoroughly before and after test for disinfection Directions Take a test
15. r Month Day Hour Minute Measurement unit The directions to setting mode Open the battery cover on the back of the meter press the setting button then a number such 2008 will blink on screen which means Year caue cro Set the Year 1 Press the front button to advance one year until you get a correct year number g 2 After you set the desired year number press the back setting button again then the meter enters into month setting 11 12 GLUC CHOL GLUC CHOL HH mgl GLUC CHOL cud mga 9 18 8e GLUC CHOL Inm LOL madl 9 iB 5 05 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 ae coL 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 Set the Minute 1 Press and release the front button until the correct minute appears 2 Press the setting button and Measurement unit mg dL or mmol L starts blinking aw qo Set the Measurement Unit nin 1 Press and release the front button until to select the unit of LILI mg dL or mmol L g g g ggw 2 Press the setting button once will finish the setting and turns off automaticall
16. strip and immediately cover the vial cap to keep the other test strips in dry condition Fully insert the contact bar of the test strip into the test port of the meter The meter will turn on automatically After CH and L_ appear on the screen the code number will follow Check the test mode and code number on the screen is the same as the one on the test strip vial Icon CHOL and GLUC indicate measuring mode of total cholesterol and glucose repectively If not remove the test strip and recode the meter 21 22 Note e The measurement test must be performed within 3 minutes otherwise 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 message E U will display on the screen Always use new test strips e If the wrong end of the test strip is inserted or if the test Strip is inserted backwards the Meter will not activate Warning uN e Lancet cannot be reused e Please always use certified lancets to ensure safety 3 2 Perform the Total Cholesterol Test Directions Insert the BeneCheck Total Cholesterol Test Strip and take a blood sample according to the instructions for lancing device in the system Touch the sample inlet of the strip blood sample until the reaction zone has been full of enough amount of blood
17. wall Manufacturer GENERAL LIFE BIOTECHNOLOGY CO LTD 5F No 240 Shinshu Rd Shin Juang Dist New Taipei City 242 Taiwan Tel 886 2 22053698 Fax 886 2 22080779 E mail service glbiotech com tw Website www BeneCheck com tw www glbiotech com tw efe MDSS GmbH Schiffgraben 41 30175 Hannover Germany C o197 PP E074 Doc No 10 RN0O1 UM 02A Aug 2012 BeneCheck Dual Monitoring System Total Cholesterol Blood Glucose User s Manual BeneCheck TABLE OF CONTENTS Chapter 1 1 1 1 2 1 3 1 4 Chapter 2 2 1 22 2 3 2 4 BeneCheck CHOL GLU Dual Monitoring System TIMER OCCU OD euran ara a nasties sean seen S ARA 1 2 Contents ofthe Kites 3 Labelling and Informations vci ic sins annnscciennraantanccwen 4 System Components ELSES Tr reinn T A 5 6 TESE SDS n ea A nae an A E anes ania 7 8 COGS Stis tiigi iee aiiin 9 Setting up the Meter Installing Replacing the Batteries SGU LAE Yeaknroassraanpiia naan na Set the Month Day Hour Minute sssessisiesssesseeriisesseesrerrrsenns Set the Measurement Unit Patient Condition Index Coding the Met r sonncssia as ARS GONE ON TSS Euu aene a a E e a ERS Chapter 3 3 1 3 2 3 3 3 4 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 How to Perform a Test Before TASEING siscrcscsassssscessnawsoversecoayessesstatuioassiceceuats teoavsevessaetiiuianieebeoniaininte Testing procedures for Blood Total Ch
18. y c mmol L 9 iB 8 08 Note e The setting items of the meter is listed as follows Please be careful to set the desired measurement unit Year gt Month gt Day Hour Measurement Unit i lt j Meter OFF mg dL ol L Minute 13 14 2 3 Coding the Meter The BeneCheck CHOL GLU Meter should be coded before testing with BeneCheck Total Cholesterol or Glucose Test Strips for the first time or every time a new box of BeneCheck Total Cholesterol or 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 a test strip is inserted please be sure to check the code number appearing on the screen is the same as the code number and test mode 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 Insert code strip into the test port of the meter BeneCheck Wait for the code number to appear on the screen fode cwe crot 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 15 16 Cautions If E 0 appears on the screen after removing the code strip there J may be a problem with the code strip Perform the coding again and if
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