GE200-User's Manual-P79-EN(CA)(101-3GM750-0A0)
Contents
1. Do not perform testing immediately after moving from one ambient temperature to another e g after coming indoors from the outside Allow 30 minutes for the temperature of the meter and the test strips to equilibrate Apply the blood sample only on the sample port of the test strip Follow local regulations or consult your health care provider for appropriate disposal of used test strips and lancets 34 35 If you are experiencing symptoms that are not consistent with your blood glucose test results and you have made sure to follow all instructions in this manual contact your healthcare professional immediately Understanding Test Results and Messages About Quality Control Testing the tes with by a you stil the tes you stil 36 result is below 1 1 mmol new test strip get a L o result contac result is above 33 3 mmo est again with a new test strip The GE200 Blood Glucose Meter displays results between 1 1 and 33 3 mmol L L Lo will appear on the screen Please repeat your test your healthcare professional L Ki will appear on the screen Please repeat your get a Hr result contac your healthcare professional mmol L l LO What is a Quality Control Test To ensure proper monitoring function it is necessary to regularly perform a quality control test Use one of the GE200 Control Solutions when testing your GE200 Blood Glucose Monitoring Syste2. GE and the GE logo are trademarks of General Electric Company and are used under license by Bionime Corporation NO 100 Sec 2 Daging Street South District Taichung City 40242 Taiwan Manufacturer BIONIME CORPORATION NO 100 Sec 2 Daging Street South District Taichung City Taiwan 40242 Made in Taiwan Distribution and Customer Service in Canada by Auto Control Medical www autocontrol com 6695 Millcreek Drive unit 6 Mississauga On L5N 5R8 Toll free 1 800 964 8434 Preface Thank you for selec ing the GE200 Blood Glucose Monitoring System This manual provides all the information you need to operate this product for accurate test results Please read this entire manual before you start any testing For people living wi complications from The GE200 Blood G or forearm h diabetes it is important to regularly monitor blood glucose levels to effectively reduce the disease The easy to use GE200 Blood Glucose Monitoring System provides accurate reliable est results to help you better manage your diabetes ucose Monitoring System is designed for in vitro diagnostic use only for single patient use and self testing only Testing requires only a small amount of fresh capillary whole blood from either the fingertip palm The GE200 Blood G any questions or co ucose Monitoring System is manufactured and supported by Bionime Corporation If you have ncerns please contact the Auto Control Medi
3. concerns please contact the Auto Control Medical Distribution and Customer Service Center at 1 800 964 8434 We will make every effort to assist you 59 Expected Glucose Values Without Diabetes Component Manufacturer Information Expected glucose values without diabetes 11 Status Range mmol L Fasting lt 5 6 Two Hours after meals lt 78 References 1 American Diabetes Association Standard of Medical Care in Diabetes 2011 Diabetes Care Vol 34 supplement 1 11 S61 January 2011 60 Blood Glucose Meter Test Strip Control Solution anufacturer Bionime Corporation 0 100 Sec 2 Daging Street South District Taichung City Taiwan 40242 Product complies with In Vitro Diagnostic Medical Device Directive 98 79 EC CE0197 EC Rep Bionime GmbH Klaus Ellensohn Tschuetschgasse 8 6833 Klaus Vibg Austria Lancing Device anufacturer Bionime Corporation 0 100 Sec 2 Daging Street South District Taichung City Taiwan 40242 Product complies with Medical Device Directive 93 42 EEC EC Rep Bionime GmbH Klaus Ellensohn Tschuetschgasse 8 6833 Klaus Vibg Austria Disposable Sterile Lancets anufacturer SteriLance Medical SuZhou Inc 0 68 LiTangHe RD XiangCheng SuZhou JiangSu 215133 P R China Product complies with Medical Device Directive 93 42 EEC CE0197 EC Rep EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands 61 Log Book Log Book ame Addres
4. lancet 18 Discard the used disposable lancet into an appropriate puncture proof or biohazard container 19 Replace the depth adjustable cap after finishing the test 30 18 19 Z CAUTION Do not apply your blood drop to the sample port on the strip until you see the appear The GE200 Blood Glucose Meter is performing an internal test and will display wg and Error if you apply blood too soon If this occurs please repeat the test with a new test strip Record the opening date of a new test strip vial Discard the vial of test strips 4 months after opening Always keep the metal contacts of the test strip port clean If any dust or impurities are present please clean with a small soft brush fe st strips The GE200 Blood Glucose Monitoring System and GE Lancing Device are intended for single patient use only Do not share these devices with anyone including other family members All parts of this kit are considered biohazards and can potentially transmit infectious diseases even after you have performed the cleaning and disinfecting procedure Users should wash hands thoroughly with soap and water after handling the meter lancing device and test strips Please refer to the section Cleaning and Disinfecting Procedures on page 47 for cleaning and disinfecting instructions 31 Alternative Site Testing Alternative Site Testing Alternative
5. Press the Right or Left button for 2 seconds The Right button is for viewing from the most current to the oldest test results The Left button is for viewing from the oldest to the most current test results Release the button to stop at any particular test result NOTE The Average function requires that the correct time and date is set Test results must exist during the desired time interval For example To get a 14 day average on 1 30 11 you must have test results dated between 1 17 and 1 30 If no test results exist during that time frame you will not receive an average To exclude test results from average calculation you need to remain in Test Mode and perform the exclusion right after you get the test result Once you move to MEM Mode Average Mode or Time Mode you will not be able to perform the exclusion The Lo Hi results control solution test results and test results under abnormal temperature lt 43 F 6 C gt 111 F 44 C will be excluded from average calculations 45 Caring for Your Meter Cleaning and Disinfecting Procedures Maintenance Keep your meter and test strip free of dust water or any other liquid Store the meter in the carrying case when not in use If your meter is dropped or damaged perform a quality control test with the control solution before performing a blood glucose test Cleaning Meter Clean the outside of the meter with a damp cloth and mild soap detergent Do not get the
6. test strip port wet Cleaning Test Strip Port If your test strip port is stained with blood control solution or any liquid please use a dry tissue or alcohol swab to clean it immediately Do not use anything wet to clean it Perform a quality control test to ensure the GE200 Blood Glucose Meter is working properly 46 ndirect transmission of Human Immunodeficiency Virus HIV Hepatitis B Virus HBV and Hepatitis C Virus HCV during the delivery of healthcare services has been increasingly reported Persons using blood glucose monitoring systems have been identified as one risk group due to the shared use of fingerstick lancing devices and point of care blood testing devices The cleaning procedure is to remove dust blood and body fluid from the surface and should be performed whenever he meter or lancing device is visibly dirty Performing the cleaning procedure once per week is recommended The disinfecting procedure is necessary to kill pathogens such as HIV HBV and HCV on the device This procedure should be performed periodically once per week is recommended f the meter is being operated by a second person who is providing testing assistance to the user the meter and ancing device should be decontaminated prior to use by the second person NOTE the cleaning procedure can only remove visible contaminates from surfaces Only the disinfecting procedure can eliminate non visible pathogens CaviWipes Disinfecting Towelettes has be
7. 00 Blood Glucose Meter with the view window facing up 11 Once the strip is inserted all symbols will appear on your meter display and will be accompanied by a beep if volume is turned on J NOTE The GE200 Blood Glucose Meter will automatically detect the Code number on the strip You do not have to check the Code number on the meter display and strip vial 28 7 12 A blood drop icon will appear on the display window and will be accompanied by a beep if volume is turned on Apply the blood sample within 2 minutes 13 Place the lancing device against your fingertip and press the release button 14 Touch and hold the blood drop to the edge of sample port until the view window is filled with blood If the view window is not completely filled with blood the test will not start If the blood sample was insufficient discard the test strip and repeat with a new GE200 Blood Glucose Test Strip 15 Countdown Mode will begin on the display window After 5 seconds your test result will appear Performing a Blood Glucose Test Performing a Blood Glucose Test 16 Pull off the depth adjustable cap Without touching the used disposable lancet insert the lancet tip into the protective lancet cover 17 Hold the release button in one hand see picture 17 step 1 and pull on the plunger with the other hand see picture 17 step 2 to safely eject the used disposable
8. E200 Blood Glucose Meter will not turn on please follow the steps Open the battery cover and remove the batteries 2 Wait for 5 minutes and reinsert the batteries as described as instructed tol Medical Distribution Er below on page 16 Meter Activation and Changing the Battery The meter should work normally after finishing the above steps If the me Distribution and Customer Service Center at 1 800 964 8434 er still does not work please contact Auto Control Medical 53 Error Messages and Troubleshooting Limitations A CAUTION GE200 Blood Glucose Monitoring System is not intended for serum or plasma testing A blood sample should ONLY be applied to the test strip after the test strip has been inserted correctly and Inaccurate test results may be obtained at altitudes greater than 10 000 feet 3 048 meters above sea level the Meter s screen is showing the image of the test strip and a blood drop flashing symbol If the blood drop Severe dehydration and excessive water loss may cause inaccurately low results flashing symbol is NOT showing on the screen do not apply a sample to the test strip Please re insert the High concentrations of Xylose 0 667 mmol L Uric acid 0 95 mmol L Ascorbic acid 0 166 mmol L unused test strip correctly Please consult your User Manual and or contact Customer Service for support on PN Na MeO a Dopamine HCI 0 082 mmol L and L Dopa 0 101 mmol L may result in inac
9. Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Medication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Glucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments 66 67 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Medication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Glucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments 68 69 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Med
10. Please re insert the unused test strip again after reviewing the steps on how to insert a test strip correctly on p 24 or call Customer Service for support This error message can also indicate that you may have used the wrong test strips Please check the test strip vial to ensure you are using the GE200 Test strips Sampling Error Please do not apply the blood to the sample port of the test strip before the meter displays Wy Discard the test strip If the meter shows Error 52 ctor O TE Er1 The inserted test strip has been used or damaged Please use a new the meter works properly Er3 The signal transmission is disrupted Repeat the test using a new tes test strip strip Er2 The meter has malfunctioned Do a Quality Control Test or reinstall the batteries to check if Er i Er c Er4 The blood sample volume is insufficient Repeat the test using a new test strip Er5 An issue calibrating the Meter has occurred Please follow the steps below Er3 Ect properly and able to Remove the test strip from the meter 2 Turn off the meter press and hold the Main button for 4 seconds 3 Press the main button one more time to turn the meter back ON after turning on the Meter you do not see Er5 your meter is functioning perform a test one of the above error messages still appears please contact Auto Con and Customer Service Center at 1 800 964 8434 Meter Malfunction the G
11. Strip Package Insert 14 15 Meter Activation and Battery Change Meter Activation and Battery Change Your GE200 Blood Glucose Meter comes with two CR2032 3volt batteries installed Two new batteries will provide power to perform approximately 1000 tests under normal use Press the main button or insert a strip to activate your meter 1 Turn the GE200 Blood Glucose 2 Install the batteries Be sure to 3 Slide the battery cover back until Meter over Press and slide put the batteries in the correct it snaps into place the battery cover to open direction polarity facing up 16 4 The GE200 Blood Glucose Meter will enter Self Testing Mode automatically when replacing the battery all symbols will appear on the screen 5 Press any button to exit the self test and enter Setting Mode 6 You must set the time and date when replacing the battery See Chapter Setting Up Your Meter Setting the Date Time and Volume on page 18 Test results are still stored in the memory CAUTION Please follow the local regulation to properly discard a used battery 17 Setting Up Your Meter Setting the Date Time and Volume Setting Up Your Meter Setting the Date Time and Volume You can enter the Setting Mode two ways 1 Replace the Battery After removing the battery press the main button several times until there is no signal on screen then follow the battery installation steps to replace battery The GE200 Bloo
12. accurate result or may prevent a meter reading An Er4 reading will be displayed if the sample size is too small In this case repeat the test with a new test strip A Important Safety Notes The GE200 Blood Glucose Meter and Lancing Device are for single patient use Do not share them with anyone including other family members All parts of the kit are considered biohazardous and can potentially transmit infectious diseases even after following the cleaning and disinfecting procedures Please refer to the section Cleaning and Disinfecting Procedures on page 47 Users should wash their hands thoroughly with soap and water before and after handling the meter lancing device or test strips Table of Contents Table of Contents About the GE200 Blood Glucose Monitoring System The GE200 Blood Glucose Monitoring System The GE200 Blood Glucose Meter The GE200 Blood Glucose Test Strip Before Testing Meter Activation and Battery CHIC Eriin anin NANG NYEKAH TANANAN DAN TIANG RARER AAEREN Setting Up Your Meter Setting the Date Time and Volume Turning On Off the Meter Turning On Off the Backlight Handling the GE200 Blood Glucose Test Strip Testing Procedure Getting ROO Tor TESUNGs aassian aana t ana inan nganah anakan aaan kaa Nah NA aga ak Andaga vielen AK aba Performing a Blood Glucose Test Alternative Site Testing View Window Appearance Understanding Test Results and MESSC GOS s ccci
13. ast 3 seconds until the C and L2 symbol appears i OPEN A CAUTION Keep pressing the main button for another 3 seconds to select the CS level you to test e res Your Control Solution Test results will not be included in the average calculations however they can still can be Level 2 Normal Level 4 High Ensure that the control solution level on the control solution D 4 recalled and viewed The Control Solution Test result will be shown with the CS icon on the screen bottle matches the level you are testing The Control Solution Test should be conducted between 43 111 F 6 44 C lt 5 You will see the blinking icon and CS icon on the screen prompting you to apply Before and CS appear do not touch the control solution to the sample port on the strip The GE200 Blood he corresponding level of GE200 Control Solution Glucose Meter is performing an internal check Touching the control solution to the sample port before prompted A will result in an error message Error and Ww and be accompanied by beeps if volume is turned on 6 Shake the bottle of GE200 Control Solution well before opening the cap Place the cap ona Do not drip the control solution on to the sample port of the test strip directly The reagent on the strip might lea lat surface into the bottle of control solution and may cause the degeneration of the control solution 7 Place a drop of control solution onto the
14. cal Distribution and Customer Service Center toll ree at 800 964 8434 We will make every effort to assist you Copyright 2011 Bionime Corporation All Rights Reserved Worldwide 1 Preface Caution The GE200 Blood Glucose Monitoring System is a personal blood glucose monitoring system to be used for self Before using the GE200 Blood Glucose Monitoring System to test your blood glucose please read all of the testing only It is not recommended for multiple patients instructions and conduct all of the tests including the quality control test Refer to page 37 Please perform the quality control test regularly to make sure the test results are accurate The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in The GE200 Blood Glucose Meter can only be used with GE200 Blood Glucose Test Strips Other brands test strips fresh capillary whole blood samples drawn from the fingertips forearm or palm The GE200 Blood Glucose should not be used under any circumstances The use of other brands strips may give inaccurate results Monitoring System is intended for self testing outside the body in vitro diagnostic use by people with diabetes at The GE200 Blood Glucose Monitoring System is intended for in vitro diagnostic use only The GE200 Blood Glucose home as an aid to monitor the effectiveness of diabetes control The GE200 Blood Glucose Monitoring System should test results using fres
15. chase optional items please contact Auto Control Medical Distribution and Customer Service Center 12 Instruction for the lancing device not shown JK at 1 800 964 8434 8 9 10 The GE200 Blood Glucose Meter The GE200 Blood Glucose Meter Display Window Left Button 10 GRR OOA Test Strip Port Main Button Right Button Product name Meter Serial Number Battery Cover Meter Battery Backlight Battery 11 The GE200 Blood Glucose Meter The GE200 Blood Glucose Meter 12 mem c Lo a NOAVG mo DCC OOo Code CS mg dL Error or CO art Key Month Day FM oo 68 88 88 MEM indicates a test result stored in memory Indicates when to apply the blood sample Indicates a test result not included into the average 6 1 t sti NO AVG results of the meter cs orale AVG Indicates the average of the test results Code Blinks when strip is not compatible with your meter or if a Error strip is inserted incorrectly Month Daj a s cs Indicates a control solution test result paga Current date under time mode or testing date under memory mode mmol L 5 si Warns when the operational temperature limit is mg dL Unit of test result exce
16. curate test results Not for neonatal use Not for screening or diagnosis of diabetes mellitus Not for use on critically ill patients in shock dehydrated patients or hypo osmolar patients Alternative site testing AST should only be performed during steady state times when glucose is not changing rapidly Alternative Site Testing should not be used to calibrate continuous glucose monitoring systems CGMS Alternative site testing should not be performed if testing for hypoglycemia Low blood glucose Results from alternative site testing should not be used in insulin dose calculation 54 55 Specification Specification Measurement Technology Dehydrogenase Electrochemical Sensor Sample Capillary whole blood Minimum Sample Volume Measuring Range 0 75 microliters 1 1 33 3 mmol L Hematocrit 10 70 Power Supply Two CR2032 Batteries Battery Life Approximately 1000 standard tests Meter Dimension 96 mm x 46 mm x 17 5 mm Test Time 5 seconds Memory Capacity Power Saving 1000 blood glucose test results with date and time Turns off automatically 2 minutes after last user action To turn off manually press the button Q for 4 seconds Meter Weight 65 5g with batteries Monitor LCD Display Area 55mm x37 mm Operating Temperature 43 111 F 6 44 C Operating Relative Humidity 10 90 56 Meter Storage Condition
17. d Glucose Meter will perform a self test Press the main button to exit the self test and enter the Setting Mode 2 With Battery Inserted Press the main button to turn on the GE200 Blood Glucose Meter Hold down the main button for 7 seconds During this time the screen will go blank until you hear a beep After the beep the meter will turn on into the Setting Mode The display screen will show setting data WA NOTE A _ Use the Left and Right buttons to select your setting data and press the main button to confirm each selection After confirming all of the settings you will return to the Time Mode 18 1 Year setting With the year format blinking press the Left or Right button until you see the current year Press the Main button to confirm Once the year is confirmed the Month Setting will appear 2 Month setting With the month blinking press the Left or Right button until you see the current month Press the Main button to confirm Once the month is confirmed the Day Setting will appear 3 Day setting With the day blinking press the Left or Right button until you see the current day Press the Main button to confirm Once the day is confirmed the Time Setting will appear 1 2 3 4H Setting Up Your Meter Setting the Date Time and Volume Setting Up Your Meter Setting the Date Time and Volume 4 Time format 12 24H selection With the time format blinking press the Left or Right button to switch betw
18. d or exposed to liquids Example If you suspect that your test results are inaccurate or if your test results are not consistent with the way you feel Exp Date 2013 06 To practice testing Required Items for Quality Control Tests To perform a quality control test prepare the items below 2 z 7 A z P FERA Ber Wipe the bottle cap with a clean tissue before tightly closing the bottle of control solution GE200 Blood Glucose Meter GE200 Blood Gi Test Stri Close the bottle of control solution tightly immediately after using 7 Poe eee est Strips Check the expiration date before use Refer to the GE200 Control Solution Package Insert GE200 Control Solution Keep control solution bottles out of reach of children 38 39 Performing a Quality Control Test Performing a Quality Control Test WN 1 Take one GE200 Blood Glucose Test Strip from the vial and close the vial cap immediately WAT 10 Tightly replace the cap on the GE200 Control Solution bottle 2 Insert the GE200 Blood Glucose Test Strip horizontally not vertically with the colored view Cl 11 The control solution result will appear Compare your Quality Control Test result to the Control window facing up into the test strip port N e Solution Range printed on the GE200 Blood Glucose Test Strip vial label While the blood drop icon is flashing on the display window press and hold the Main button for at le
19. ed to ensure that there is no change in the performance of the 4 Your GE200 Blood Glucose Meter has been tested to ensure that there is no change in the performance or device after550 cleaning cycles and 550 disinfecting cycles The testing simulates 2 cleaning and external materials of the device after 550 cleaning cycles and 550 disinfecting cycles The testing simulates disinfecting cycles per week over the typical life of the meter 5 years 2 cleaning and disinfecting cycles per week over the typical life of the meter 5 years 48 49 Cleaning and Disinfecting Procedures Error Messages and Troubleshooting A CAUTION Temperature Error Users should wash their hands thoroughly with soap and water after handling the meter lancing device or test strips 1 In order to get accurate testing results please test between 6 44 C 43 111 F Please examine your LCD screen test strip port buttons and surface of your meter and lancing device after cleaning and disinfecting cycles Stop using the meter and or lancing device if any of the following 2 When the temperature is below 6 C 43 F or over 44 C 111 F the meter will not function occur i a ii Thin sliver streaks appear on the screen and the Error symbol will blink The screen becomes cracked soft dissolved brittle or swollen You are unoble to turn on off your meter operate the right left button the lancing device 3 If the GE200 Blood Glucose Mete
20. eded during testing 888 Test result Ad Indicates the time in 12H format oq Warns when the batteries are low or must be replaced Displays current time under time mode or testing time under memory mode OK EN Check Key manufacturing use only 13 The GE200 Blood Glucose Test Strip The GE200 Blood Glucose Test Strip The GE200 Blood Glucose Meter can only be used with GE200 Blood Glucose Test Strips and GE200 Control Solution The use of other test strips or control solutions can lead to incorrect results Electrode Contacts Sample Port Apply blood control solution here PRECAUTION Close the GE200 Blood Glucose Test Strip vial immediately after removing a test strip Do not reuse GE200 Blood Glucose Test Strips Do not use expired GE200 Blood Glucose Test Strips Noble Metal Electrodes When you open a new vial of GE200 Blood Glucose Test Strips record the date on the vial Discard the vial Hold here to of test strips after 4 months from opening RICE iroenemica Sensor insert test strip Store the GE200 Blood Glucose Test Strip between 39 86 F or 4 30 C and in a location into meter lt 90 relative humidity Do not expose to direct sunlight or heat If the GE200 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperature View Window please wait 30 minutes before measurement For detailed information please refer to the GE200 Blood Glucose Test
21. een 12H and 24H Press the Main button to confirm Once confirmed the Hour Setting will appear 5 Hour setting With the hour blinking press the Left or Right button until you see the current hour Press the Main button to confirm Once the hour is confirmed the Minute Setting will appear 6 Minute setting With the minutes blinking press the Left or Right button until you see the current minute Press the Main button to confirm Once the minute is confirmed the Volume Setting will appear 20 4a i Ng mh att me a PH PUH I E f wn o izon p q HHH 6 6 PUH Month Day aor PO Ls uu 4h ms 5 idu 7 Volume Setting 7a 7b With the volume blinking press the Left or Right button to turn the volume on or off Press the Main button to confirm and finish the an or LI LIL LI LIL vf 1 On OFF settings NOTE If you do no change any settings during Meter Set up for over 2 minutes the GE200 Blood Glucose Meter will leave setting mode and power off automatically 21 Turning On Off the Meter Turning On Off the Backlight 1 How to turn on the GE200 Blood Glucose Meter 1 Turn on the backlight Press the Main button or Insert a test strip Press and hold the Main button for 2 seconds 2 Manual Power off 2 Manually turn off the backlight To power off the GE200 Blood Glucose Meter press and hold the Main button for 4 seconds With the backlight on p
22. en tested and may be used to clean and disinfect the meter and lancing device Users may purchase the disinfecting wipes from the manufacturer Metrex distributors or major on line retail sites such as amazon com 47 Cleaning and Disinfecting Procedures Cleaning and Disinfecting Procedures To clean the lancing device 1 NOTE aides lt a Clean and disinfect the outside of the device only Do not remove battery cover when cleaning and disinfecting 1 Throughly wipe the entire surface of the lancing device with disinfecting wipes benar ranangga i listed above to clean any possible dirt dust blood and other body fluids oc 1 Throughly wipe the entire surface of the meter with disinfecting wipes listed above to clean any possible dirt dust blood and other body fluids To disinfect the meter Q 2 Take another disinfecting wipe and wipe the meter thoroughly Note AIl blood and body fluids should be cleaned from surface before performing the disinfecting procedure 3 Allow the surface to remain wet for 2 minute 4 Allow to air dry To disinfect the lancing device 2 Take another disinfecting wipe and wipe the Lancing device thoroughly Note All blood and body fluids should be cleaned from surface before performing disinfecting procedure 3 Allow the surface to remain wet for 2 minute 4 Allow to air dry WA Note ZA NOTE Your GE Lancing Device has been test
23. er only if used as directed and provided that the failure to Doctor Hospital immediately Or call perform has not been caused in whole or in part by the use of test strips that are not GE200 Blood Glucose Test Strips manufactured by Bionime Use only GE200 Blood Glucose Test Strips in your GE200 Blood Glucose Meter 3 The sole obligation of Bionime under this warranty shall be to replace any defective GE200 Blood Glucose Meter No other warranties express or implied are made Bionime shall not be responsible for any incidental or consequential damages Se cee a Ng en a aa nny nner AE EE 4 You must contact your distributor for assistance and or instructions for obtaining a replacement GE200 Blood Glucose Meter Please fill this card and carry with you at all times g 78 79
24. h capillary whole blood samples from the fingertip palm and forearm are calibrated to be the not be used for diagnosis of or screening for diabetes or for neonatal use equivalent to that of plasma testing The GE200 Blood Glucose Monitoring System is intended for self testing It should not be used to diagnose diabetes A healthcare professional should be contacted when Customer Service is not available mellitus If the GE200 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperature please wait Please forward your warranty card 30 minutes before measurement Auto Control Medical Follow all environmental protection regulations when disposing of batteries 6695 Millcreek Drive unit 6 The GE200 Blood Glucose Meter will be set as mmol L by default when sold in Canada If meter display shows Mississauga On L5N 5R8 mg dL during setting or test please contact Auto Control Medical Distribution and Customer Service Center Toll free 1 800 964 8434 at 1 800 964 8434 Use of the wrong unit of measurement may cause incorrect treatment 2 3 Caution Caution Avoid contact with dripping or splashing liquids The minimum blood sample size to test using the GE200 Blood Glucose Monitoring System is 0 75uL e Sample Size Example O 75uL 1OpL 1 5yL 2 0uL 3 0pL e e e e Blood sample size above 3 0uL might contaminate the test strip port and the meter Blood sample size below 0 75uL may cause an in
25. ication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Glucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments 70 71 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Medication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Glucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments T2 73 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Medication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Gl
26. m in the Control Solution Mode If the test result is within the Control Solution Range printed on the strip vial label the GE200 Blood Glucose Monitoring System passes the Quality Control Test and your GE200 Blood Glucose Monitoring System is working properly Control Solution Range Example of Control Solution Range printed on your test strip vial label 10 test strips g Ss Control Solution Range mmol L Normal Level 2 4 9 6 7 High Level 4 13 8 18 8 NOTE If you want to purchase Level 2 Normal control solution please contact the Auto Control Medical Distribution and Customer Service Center at 1 800 964 8434 toll free at 1 800 964 8434 37 About Quality Control Testing About Quality Control Testing When should a Quality Control Test Be Performed CAUTION To ensure that your GE200 Blood Glucose Meter and GE200 Blood Glucose Test Strip are working properly Each time you open a new bottle of control solution write the expiration date on the label The GE200 To confirm that you are following the correct testing procedures Control Solution is good for 3 months after opening the bottle or until the expiration date printed on the To prepare for your initial blood glucose test label whichever comes first To check the GE200 Blood Glucose Test Strip when you open a new vial of strips To check your GE200 Blood Glucose Meter after it has been dropped damage
27. ngertip If you use the normal lancing device for your palm or forearm the blood sample may not be sufficient for meter operation Periodically compare the test system to a laboratory test system that is known to be well maintained and monitored by a healthcare provider 33 View Window Appearance Understanding Test Results and Messages Make sure your blood sample covers the whole area of d J Blood glucose test results are shown on the GE200 Blood Glucose Meter as mmol L the view window to get an accurate test result An insufficient blood sample will result in an error message N N If your blood glucose result is unusually high or low or if you question your test results repeat the test with a new Er4 If this occurs repeat the test with a new test strip gt GE200 Blood Glucose Test Strip ed MA You can also run a Quality Control Test with the GE200 Control Solutions to check your GE200 Blood Glucose Meter Insufficient blood sample Sufficient blood sample and GE200 Test Strip Refer to Performing a Quality Control Test on page 40 A CAUTION Check the expiration date printed on the strip vial every time you use a test strip Do not use expired GE200 If the test result still remains unusually high or low contact your healthcare professional immediately Blood Glucose Test Strips Use each GE200 Blood Glucose Test Strip immediately after removing it from the vial Do not reuse GE200 Blood Glucose Test Strips
28. r and Test Strips are exposed to a substantial change in release button or depth adjustable cap temperature please wait 30 minutes before measurement You are unable to enter meter settings function modes or recall your testing results If you have any questions or concerns please contact your GE200 Blood Glucose Monitoring System authorized representative or call the Auto Control Medical Distribution and Customer Service Center toll free at 1 800 964 8434 50 51 Error Messages and Troubleshooting Error Messages and Troubleshooting Battery Error 1 The Ca and Error symbols appear and the meter will not function when the battery is low Change the batteries immediately NOTE L The backlight function operates off of its own battery source If the backlight is no longer functioning replace the backlight battery Refer to page 11 to find the location of the backlight battery When the backlight no longer operates the meter will still function for testing purposes until the TA and Error symbols appear as described above Strip Error 1 When the test strip is inserted incorrectly the meter will beep 4 times while the 8 flashes Do not apply a sample on the test strip Please re insert the unused test strip correctly 2 If after performing the required steps the C and flashing Error symbols appear on the screen it means the GE200 Test strip has been inserted incorrectly more than twice
29. ress and hold the Main button for another 2 seconds 3 Auto Power off 3 Auto shutoff The GE200 Blood Glucose Meter will power off automatically after 2 minutes if no buttons are pressed or no strip is The GE200 Blood Glucose Meter backlight will turn off automatically after 10 seconds if no buttons are pressed inserted 22 23 Handling the GE200 Blood Glucose Test Strip Handling the GE200 Blood Glucose Test Strip How to handle the GE200 Blood Glucose Test Strip Inserting the GE200 Blood Glucose Test Strip 1 Hold the GE200 Blood Glucose Test Strip between your thumb and middle finger with the view window D facing up 2 Put your forefinger on the side of the strip as shown 3 Insert the GE200 Blood Glucose Test Strip into test strip port until it clicks and firmly stops 24 Removing the GE200 Blood Glucose Test Strip 1 2 1 Hold the GE200 Blood Glucose Test Strip as shown E Qu 2 Rotate the GE200 Blood Glucose Test Strip counterclockwise and pull up simultaneously Pag i cma 3 Take the GE200 Blood Glucose Test Strip out of the test strip port 3 Please follow your local regulations and discard used strips properly Pe e 25 Getting Ready for Testing Performing a Blood Glucose Test Before performing a blood glucose test prepare the items below GE200 Blood Glucose Meter GE200 Blood Glucose Test Strips Please check the expiration date on the te
30. results View the 1 day 7 days 14 days 30 days 60 days and 90 days average test results for better blood glucose monitoring sawahi moan mmol mrata mo mn S8 oo 59 59 Bil bi AT i ap 4B MH m m o 8 A 1 Press the Main button to switch the screen to Average Mode 2 On the average screen use either the Left or Right button to view 1 day 7 days 14 days 30 days 60 days or 90 days averages 3 The number shown in the lower right hand corner indicates how many test results have been calculated 4 Excluding test results from the average calculation You may exclude the test result from average calculation right after each test You have to perform this exclusion immediately after the meter displays the reading of your test result Press the Right button until the symbol NO AVG appears in the upper right of the screen Keep pressing the Right button while simultaneously pressing the Main button until NO AVG appears The test result is now excluded from averaging 44 To recover excluded test results and include them in the average calculation do not leave the current mode Press the Right button until the symbol NO AVG changes to AVG Keep pressing the Right button and while simultaneously pressing the Main button until AVG appears The excluded test result is now included into the average calculation 5 Quick Searching To view test results in sequential order automatically enter the Memory Mode
31. s Test Strip Storage Conditions 10 60 C 14 140 F 4 30 C 39 86 F lt 90 relative humidity 57 Warranty Customer Service Bionime Corporation warrants that this product will be free from defects in materials and workmanship for five years from the date of purchase This warranty does not apply to the performance of a GE200 Blood Glucose Meter that has been altered misused tampered with or abused in any way This warranty applies only to the original purchaser of the GE 200 Blood Glucose Monitoring System Please complete and return the enclosed warranty card Different models have different specifications This warranty applies only to the GE200 Blood Glucose Monitoring System other models are not covered with this warranty card GE is a trademark of General Electric Company and is under license by Bionime Corporation NO 100 Sec 2 Daging Street South District Taichung City 40242 Taiwan R O C NOTE During blood glucose measurement the GE200 Blood Glucose Meter itself may come into contact with blood All parts of the GE200 Blood Glucose Monitoring System are considered biohazardous and can potentially transmit infectious diseases Please follow your local regulations to properly dispose of the used GE200 Blood Glucose Monitoring System after removing the batteries 58 Please review all of the instructions to make sure you are performing the steps correctly If you have any questions or
32. s Home Phone Doctor Pharmacy nsulin Pills n case of emergency contact 62 Work Phone Doctor s Phone Pharmacy Phone Log book date From To DATE M T WwW T F S S Blood G Breakfast PO0e SIUCOSE Insulin Medication Blood Glucose Lunch Insulin Medication h Blood Glucose Dinner Insulin Medication Blood Glucose Bedtime Insulin Medication Blood Glucose Other Insulin Medication Comments 63 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin Medication Insulin Medication Blood Glucose Blood Glucose Lunch Lunch Insulin Medication Insulin Medication Blood Glucose Blood Glucose Dinner Dinner Insulin Medication Insulin Medication Blood Glucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments 64 65 Log Book Log Book DATE M T W T F 5 S DATE M T Ww T F 3 S Blood G Breakfast 8 099 Glucose Breakfast 290 5ucose Insulin
33. site testing palm or forearm blood sampling To perform alternative site testing install the clear cap for your GE Lancing Device For detailed information refer to the instruction manual for the GE Lancing Device To increase the blood flow massage the intended puncture area of your palm or forearm for a few seconds Immediately after massaging the intended puncture area press and hold the lancing device with the clear cap against palm or forearm Press the release button Continue holding the lancing device against your palm or forearm and gradually increase pressure for a few seconds until the blood sample size is sufficient DO NOT test on the palm or forearm if you are testing for hypoglycemia Low blood glucose 32 CAUTION Test results may vary if blood samples are taken from different sites or under certain conditions where glucose levels are changing rapidly such as following a drink a meal an insulin dose or exercise In these cases only the fingertip should be used DO NOT test on the palm or forearm if you are testing for hypoglycemia Low blood glucose Fingertip samples can show the rapid change in glucose faster than palm or forearm samples Consult your healthcare professional before sampling from your palm or forearm Since the blood flow in the forearm and palm is slower than in the fingertip use the clear cap provided with the GE Lancing Device when testing sites other than fi
34. ssccserisnsiiseniensnaspiveiviviniscstbientasesives i E AR Bn RA R EE E ENR 35 6 Quality Control About Quality Control Testing Performing a Quality Control Test Understanding Control Test Resul Test Memory Recalling Test Results Recalling Average Test Results Caring for Your Meter Cleaning and Disinfecting Procedures Error Messages and Troubleshooting Limitations Specifications Customer Servic Expected Blood Glucose Values Without Diabetes Component Manufacturer Information Log Book Warranty C Emergency Card The GE200 Blood Glucose Monitoring System The GE200 Blood Glucose Monitoring System Contents Your GE200 Blood Glucose Monitoring System consists of several items Please identify each item learn its name and how itis used 3 _ 5 4k s CONTROL SOLUTION Below are the items included in your GE200 Blood Glucose Monitoring System 1 Getting Started Guide 2 User s Manual includes Log Book Warranty Card Emergency Card 3 GE200 Blood Glucose Test Strip Package Insert 4 GE200 Control Solution Package Insert 5 GE200 Blood Glucose Meter with 2 CR2032 batteries installed 6 GE200 Blood Glucose Test strips 10 25 pcs 7 GE200 Control Solution available as Normal Level 2 and High Level 4 8 GE Lancing Device 9 Clear Cap 10 Disposable Sterile Lancets 10 pcs 11 Carrying Case not shown If you want to pur
35. st strip vial Do not use expired test strips GE Lancing device Sterile lancet Alcohol swab optional 26 Po test stripsi y Ss Depth adjustable cap pee button Car A Lancet carrier Base PE y Un a Hold the depth adjustable cap in one hand and hold the base with the other hand Pull off the depth adjustable cap Insert a new disposable lancet firmly into lancet carrier Twist off and set aside the protective cover of the disposable lancet Replace the depth adjustable cap Bend the cap down When a gap appears between the cap and base pull the cap and base in opposite directions Choose a depth of penetration by rotating the top portion of the depth adjustable cap until your desired setting is visible in the window Settings are based on skin type ax for soft or thin skin amb for average skin amm for thick or calloused skin Performing a Blood Glucose Test Performing a Blood Glucose Test 7 Hold the base in one hand and pull on the plunger with the other hand The device will be cocked Release the plunger and it will automatically move back to its original position near the base 8 Wash your hands with warm soapy water and dry thoroughly 9 Take one GE200 Blood Glucose Test Strip from the vial Close the vial cap immediately 10 Insert the strip into the test strip port of the GE2
36. t be working properly Repeat the Quality Contro not use GE200 Blood Glucose Meter to test your blood g Test If your control solution results are still out of range do ucose Please contact the Auto Control Medical Distribution and Customer Service Center toll free at 1 800 964 8434 42 The GE200 Blood Glucose Meter is able to automatically store a maximum of 1000 test results with time and date If your meter has stored 1000 results the newest test result will replace the oldest one To recall your test memory start the meter without a test strip inserted 1 Press the Main button to switch from the Time Mode to Memory Mode You will see the mem mem mmol L icon in the upper left corner of the display The latest test result will appear with the number 1 i 2 Use either the Left or Right button on the side to review all previous results with date and time Results display from the most recent Sequence no 1 to the oldest Sequence no 1000 in 2a 43 the lower right hand corner of the screen men mmol L 3 The Quality Control Test result can be recalled from the saved data When CS appears next to the data the test was performed using the GE200 Control Solution The control solution test result will not be used when recalling test average results ies oe b i i 43 Recalling Average Test Results Recalling Average Test Results The GE200 Blood Glucose meter provides several average test
37. top of the cap bv This could contaminate the meter via the test strip port 8 Gently touch the sample port of the strip with the control solution from the top of the cap 5 Keep the test strip port clean and dry Clean immediately if the test strip port is stained or is overly 9 The screen will display the count time starting from 5 you will hear a beep if the volume is fool exposed to moisture e ae urned on a Do not touch the tip of the control solution bottle If the tip is touched clean with water 40 Understanding Control Test Results Recalling Test Results Your control solution test results should fall within the control solution range If the results are within the range the GE200 Blood Glucose Monitoring System is working correctly Control Solution Range L2 Level 2 Normal L4 Level 4 High 49 67 mmol L 13 8 18 8 mmol L Possible reasons your Control Solution results are out of the range Your GE200 Control solution is expired or was first opened more than 3 months ago Your GE200 Blood Glucose Test Strip has expired You left the cap of the Blood Glucose Test Strip vial or You did not perform the test procedure correctly he control solution off for a period of time The GE200 Blood Glucose Meter or GE200 Blood Glucose Test Strip have malfunctioned If GE200 Control Solution results are out of range your GE200 Blood Glucose Monitoring System may no
38. ucose Blood Glucose Bedtime Bedtime Insulin Medication Insulin Medication Blood Glucose Blood Glucose Other Other Insulin Medication Insulin Medication Comments Comments 74 75 Log Book Warranty Card DATE Blood G Breakfast 7000 Slucese Insulin Medication Blood Glucose Lunch Insulin Medication Blood Glucose Dinner Insulin Medication A Blood Glucose Bedtime Insulin Medication Blood Glucose Other Insulin Medication Comments 76 oo Distributor name and address PLACE STAMP HERE 77 Warranty Card 2 Emergency Card Narie Tel Distributor name and address EMERGENCY CARD 3 GE200 Blood Glucose Monitoring System Address e User Name Serial No Model Date of purchase FG Emergency Contact Phone No I am a diabetes patient If Limited warranty Please present this card for product replacement you find me unconscious or 1 Bionime warrants to the original purchaser only that the GE200 Blood Glucose Meter shall be free of any defects in materials or e Blood Type dazed please contact workmanship and provided it is not modified altered or misused will perform in accordance with specifications for a period of five 5 years from the original date of purchase ONE NENGA Selves 2 Bionime guarantees the performance of the GE200 Blood Glucose Met
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