Blood Glucose / Cholesterol 2 in 1 Monitoring System
Contents
1. GLUC 4 mg dL a ty 2 deem Model TBG 460GC Blood Glucose Cholesterol 2 in 1 Monitoring System User s Manual 2012 03 12 Rev 00 Table of Contents Chapter 1 TBG 460GC Monitoring System VA INTPOGUCHION lt lt 0 02 c0scenereeeacdaccacsacanencnasacenseasetedeccnnaesees cesccaesanens 2 UZ Precautions nssr a aera aenta 2 11 3 Intended USC vo cics ce traysceen nadie hess areciegenene 3 1 4 Labelling and Informations c ccccceceeeeeeeeeeeeeeeeseeeeeeeeees 4 1 5 System Components seriean aisnean naraon aa 4 Chapter 2 Setup the meter 2 1 Set the Year Month Day Hour Minute Measurement unit 6 Chapter 3 How to perform Test 39 A Before TeSting reren EN EE EEEE NNE 7 3 2 Perform the Blood Glucose TeSt c ccecseceeeeeeeeeeeeteeeteeeee 9 3 3 Perform the Total Cholesterol Test ccceceeeeeeeeeeteeees 10 3 4 Special Message Saimantien ayie aa onein 11 3 5 Care after the testin ccoesticesctes ne necwisiensigeevanerstenesseciys 11 Chapter 4 Quality Control isiro 12 Chapter 5 Meter Memory Function cccceceeeeeeeeteeeeeeteeees 13 Chapter 6 Installing Replacing the Batteries 14 Chapter 7 Storage and Handling of Meter and Strips 15 Chapter 8 Error Message and Trouble Shooting 000 15 Chapt r 9 Specificato Missas 17 Chapter 1 TBG 460GC Monitoring System 1 1 Introduction Thank you for choosing Blood Glucose Cholest2. babies 225 Handle the strip with clean and dry hands lancing site for the test should be cleaned and dried thoroughly Do not perform the test while a cell phone is used beside prevent the electronic signal interference Oxygen concentration in air is low 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 result Hct above 55 may cause reduced glucose results versus a whole blood reference Do not drop the product Keep the lancets and lancing device out of the reach of the children Keep the meter and test strips at room temperature 10 30 C 1 3 Intended Use TBG 460GC Blood Glucose and Cholesterol Monitoring System is intended to be used for quantitative measurement of blood glucose level and cholesterol level in fresh capillary whole blood drawn from the fingertips It is intended for use outside of body In Vitro diagnostic use It should be use only as an aid to monitor blood glucose and cholesterol level by individuals at home and by healthcare professionals at clinical settings 23 1 4 Labelling and Informations Caution consult Keep dry accompanying documents Do not
3. hour appears 2 Press the memory button and the minute segment will start blinking Set the Minute 1 Press up down button until the correct minute appears 2 Press the memory button then measurement unit segment starts blinking 1 Press the up dowm button until the correct measurement unit appears 2 Press the memory button will show OFF on the screen and power off Chapter 3 How to perform Test 3 1 Before Testing Coding the Meter TBG 460GC meter should be coded before testing with test Strips for the first time or every time a new box of 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 marked on the test strip vial Directions 1 Insert code strip into the test port of the meter Wait for the code number and test mode to appear on the screen 2 Make sure the code number on the nan screen is the same as the code o9 number on the code strip and the test mode is also the same as marked on the test vial Remove the code strip should appear on the screen indicating that the meter has been successfully coded A Cautions If E E appears on the screen during coding procedure there may be a problem wi
4. re use C Read instructions Operation Storage vo In vitro diagnostic EU Representative Catalogue number ao c Operation temperature 30 c Storage temperature 10 C limitation 10 C limitation IVD LOT Product number tor Lot number Manufactured by g3 Use by H g C 0123 CE certification 1 5 System Components Meter Front Side Test Sirio Por est Strip Port Insert test strip here The meter will turn on automatically LCD Screen For display of operating information and test results Memory Button Enter memory mode operation Down Button Up Button 4 Meter Back Side Glucose Test Strip Blue Color Electronic Contact Bar Insert Electronic Contact Bar of the test strip into the Test Port of the meter to activate it a Cholesterol Test Strip Yellow Color Electronic Contact Bar Insert Electronic Contact Bar of the test strip into the Test Port of the meter to activate it Reaction Zone Reaction zone of Total Cholesterol Battery Cover For holding a 3V lithium battery Tag Display information about the meter Sample Inlet The inlet where the whole blood or control solution is drawn in Touching a blood sample or control solution will result in a capillary action automatically Sample Inlet 4 The inlet where the whole blood or control solution is drawn in Touching a blood s
5. strips at room temperature Do not expose them beyond the range described in Chapter 8 Do not freeze or refrigerate the meter and strips Keep the meter clean by wiping the exterior of the meter with a tissue or lint free cloth Chapter 8 Error Message and Trouble Shooting Message Cause Solution E 0 There will be a problem with Repeat the test with a new test the test strip strip If the problem persists please contact the dealer for service E 9 The test strip may be Revlew the instructiona and try removed after applying again with a new test strip blood the absorbent hole If the problem persists please contact the dealer for service E b The power of the battery is Replace the battery at once too low to run a test E A The reference voltage or Call local authorized distributor other circuit is error for help and service 5 Message Cause Solution E E 1 There may be a problem Power off then retry if the error with self check of the appears again contact the meter authorized distributor for service 2 Use of the wrong or Check that the code number on damaged code strip or the meter display matches the the code strip was code number on the test strip inserted improperly vial Code the meter or retest as necessary If the error message appears again please contact the dealer for service E t amp The temperature is below Repeat the test after the meter
6. 11 mmol L gt 600 mg dL 33 3 mmol L Total Cholesterol lt 100 mg dL 2 59 mmol L gt 400 mg dL 10 35 mmol L 3 5 Care after the Test Directions 1 Improper usage of the meter such as dropping bumping or other violent impact may cause the meter damaged 2 Please keep meter away by interferences of magnetic electromagnetic and radioactive Ya Warning 1 Do not disassemble the meter for any reason 2 Please follow local regulations to discard used test strips and lancets 3 Used test strips lancets and any other materials that have come in contact with blood should be treated as potential biohazards If a user has an infectious disease used test strips and other materials could be a sources of infection Ne aA 1 Chapter 4 Quality Control Intended to use The control solution is used to check the performance of the system including Blood Glucose and Cholesterol Monitor System Glucose and Cholesterol strip user s test skill The system is performing adequately if the control solution test result falls within the indicated control range listed on the test strips vial label A control test should be proceeded 1 When you suspect that the meter or test strips are not working properly 2 When your blood glucose or cholesterol test results are not consistent with how you feel or when you think your results are not accurate 3 When you drop or bump your meter 4 Upon the advice of the healt
7. Temperature or above the system and the test strip have reached Icon Sign operating range at temperature within the operating range E U It could be caused by a Repeat the test with a new test used test strip or a strip If the error message temporary or permanent appears again please contact electronic problem the dealer for service HI 1 Blood glucose level is 1 Review the instructions and higher than 600 mg dL try again with a new test 2 Test strip has problem strip 2 Check the test strip vial to make sure that it is not marked beyond the expiration date Lo 1 Blood glucose level is 1 Review the instructions and lower than 20 mg dL 2 Test strip has problem try again with a new test strip Check the test strip vial to make sure that it is not marked beyond the expiration date N 16 Chapter 9 Specification System Accuracy 20 at Glucose level gt 75 mg dL 4 17mmol L 20 at Total Cholesterol 2 150mg dL 3 88mmol L Principle Electrochemical Biosensor Calibration Plasma equivalent Test Sample Fresh Capillary whole blood Measuring Time About 10 seconds Glucose 26 seconds Total Cholesterol Measuring Range Glucose 20 600 mg dL 1 1 33 3 mmol L Total Cholesterol 100 400 mg dL 2 59 10 35 mmol L Sample Volume About 1 1 5 uL Glucose About 10 uL Total Cholesterol Hematocrit Range 30 55 for Glucose 35 50 for Total Cholestero
8. ample or control solution will result in a capillary action automatically At least 10uL of blood sample is essential 25s Code Strip Front View Contact Bar Insert this end into Code Number the Test Port of the a Test Mode meter GLUC Glucose CHOL Total Cholesterol H C EH cHoL A412 ERA eee Chapter 2 Setup the meter 2 1 Set the Year Month Day Hour Minute Measurement unit Press and hold the memory button for over three seconds the meter will sound one beep and enter the setting mode Please follow the directions below to set the meter Under the setup mode the LCD screen of the meter shows all setting items start from a blinking year 20XX and the rest setting items are listed as follows Set the Year 1 When the meter enter setting mode the first item on the screen such as 2012 will blink on screen which means Year 2 Press the up down button to until the correct year appears 3 After you set the desired year number Press the memory button again then the month segment starts blinking Set the Month 1 Press the up down button until the correct month appears 2 Press the memory button and then the day segment starts blinking Set the Day 1 Press up dowm button until the correct day appears 2 Press the memory button and the hour segment will start blinking Set the Hour 1 Press up down button until the correct
9. erol Monitoring System Please read the User s Manual for your convenient and for safe use The Blood Glucose Cholesterol Monitoring System provides you with accurate plasma calibrated results based on electrochemical sense technology and the superior capillary sampling The Blood Glucose Cholesterol Monitoring System require only a small amount of blood the result is precisely calculated and displayed Please read the entire User s Manual carefully before using the Blood Glucose Cholesterol Monitoring System The User s Manual guides you through the operation procedures with illustrated directions and help you find the required informations Please contact the local distributor for questions and enquiries WARNING Please carefully read the instructions in this User s Manual and become familiar with the test procedures before using the system User should do the quality check and consult with a healthcare professional before doing any important medical decision 1 2 Precautions Please observe the following limitations for obtaining accurate results of Blood Glucose Cholesterol Monitoring System The measurements are only for reference purposes For an analysis of the measurements consult specialists For In vitro diagnostic use only External use only Single use only please do not reuse the test strip Do not use this product for those who cannot express their opinions properly including infants or
10. hcare professional How to perform a control test 1 Insert a test strip into the test strip port of the meter and immediately cover the vial to keep the strips in dry condition 2 Be careful to make sure the test mode and code number on the screen are the same as the one marked on the test strip vial If not remove the test strip and re code the meter to correct test mode and code number 3 Shake the control Solution vial vigorously then open the cap to discard the first three drops of control solution after wiping the dispense tip and cleaning with tissue then drop some control solution onto a clean object such as transparency If it is a cholesterol test Please drop out enough control solution at least 10uL 4 Touch the Sample Inlet of the Glucose or Cholesterol Test Strip to the drop of Control Solution until the Meter sounds a beep The screen will display a count down from 10 seconds for Glucose Test Strip or 26 seconds for Cholesterol Test Strip 5 After counting down the Screen will display the control Test results Compare the results to the control range listed on the Test Strip Vial Warning J2 Please read this user s manual for control solution test carefully before use Do not reuse the Test Strips and close the Test Strip Vial lid tightly after use The first three drops of Control Solution must be discarded and the vial should be shaked well before use when the vial is newly opened Newly o
11. l Strip Storage Condition 10 30 C 50 86 F Operation Temperature 10 40 C 50 104 F Relative Humidity Less than 95 Memory 360 for Glucose 50 for Total Cholesterol Battery Type One 3V CR2032 lithium battery Battery Life Approximately 1 000 tests Dimensions 82 54 21 5mm Length Width Height Weight About 45 g with battery 17
12. nd total cholesterol respectively If not remove the test strip and re code the meter 3 Obtain a drop of blood with a lancing device Do not squeeze your fingertip hard to obtain a drop of blood It may influence the result 4 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 5 The screen will display a count down from 10 seconds for glucose testing 3 3 Perform the Total Cholesterol Test 1 Insert a Total Cholesterol test strip yellow color into the test strip port of the meter and follow the procedure as performing the blood glucose test 2 Make sure to get enough blood sample volume 3 The screen will display a count down from 26 seconds for cholesterol testing y 7 Note 1 The TBG 460GC Monitoring System includes glucose and total cholesterol test that are all plasma calibrated The user does not have to convert it into plasma result 2 Use the strips before the expiry date the strips can only be used within 3 months remaining shelf life after the first opening of the vial 3 Apply the blood sample onto the correct position of the strip precisely follow the directions to avoid incorrect operations 4 Prohibited applying the blood sample to the test strip twice it will cause inaccurate test results Ms 3 4 Special messages Mode Lo Hi Glucose lt 20 mg dL 1
13. ored result M01 appears on the screen Then you can read the stored result from M01 to M360 Glucose mode or from M01 to M50 Cholesterol mode by pressing Down or UP Button 6 Press the memory button for over 3 seconds and the meter will turn off after a long beep sound Meter will also automatically shut down after 3 minutes without any operation r Note If 360 test results are already stored and a new one is added the oldest test result is automatically overwrited The newest result will be shown in M01 Chapter 6 Installing Replacing the Batteries Batteries A 3V 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 1 Hold the meter with one hand slightly lift the back cover lid to open the back cover 2 Insert a new battery in the meter with the side facing up you will hear a beep sound which indicates that meter is ready 3 Place back the cover onto the meter 74 Chapter 7 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 Store the meter code strip test
14. pened vial of Control Solution and Test Strips must be marked with the opening date Glucose Control Solution is used for glucose test mode And Cholesterol Control Solution is used for cholesterol test mode If the test results fall outside the control range please reconfirm and repeat the test if it is still fall outside the range please contact authorized distributor for help and service Control solutions are not included in the system please contact your distributor if you want to do a quality control test Chapter 5 Meter Memory Function TBG 460GC meter automatically stores up 360 blood glucose and 50 cholesterol test results It also provides you with 7 14 21 and 28 day averages of the blood glucose test results 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 memory button once to turn the meter on After a short beep sound a full display will appear on screen then the meter enters standby mode Note The day average function can be applied to glucose test mode only total cholesterol test mode do not have the day average function 3 Press the memory button once again and the meter stays at memory mode The 7 day average 7 DAY A will display on the screen 4 Followed by 14 21 and 28 day average when press the memory button repeatedly 13J 5 After the 28day average the latest st
15. th the code strip or a wrong category code strip may be misused Perform the coding procedures again and if E E continues to appear please contact the authorized distributor for service Use of Lancing Device 8 1 Remove the end cap by gently pushing it down and away from the lancing device 2 Insert the lancet firmly into the lancet holder until it comes to a stop and remove the protective lancet cover 3 Replace the end cap by snapping it back onto the lancing device body 4 Select the skin penetration depth by turning the depth selector until the desired number can be seen in the selection window 5 levels of skin penetration The higher the number the deeper it pricks 5 Pull the part located at the back of the device until it comes to a stop and then release 6 Place the lancing device firmly against the finger and press the release button to obtain a blood sample After finishing your blood test dispose the used lancet safely in an appropriate container 3 2 Perform the Blood Glucose Test Directions 1 Insert a Blood Glucose test strip blue color into the test strip port of the meter and immediately cover the vial to keep the strips in dry condition The meter will turn on automatically 9 2 Be careful to make sure the test mode and code number on the screen are the same as the one marked on the test strip vial Icon GLUC and CHOL indicate measuring mode of glucose a
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