GE100 Blood Glucose Monitoring System User Manual
Contents
1. Tay ITTY cw Month Day h 7 re r A hon Setting Up Your Meter Setting the Time Volume and Date Turning On Off the Meter 8 Ending setting a N 1 How to turn on the GE100 Blood Glucose Meter After the Volume Setting the GE100 will return to the time screen If the Press the Main button or insert a test strip volume has not been turned off you will hear a beep 2 Manual Power off Month Day c g pmwnn If you want to turn off the GE100 Blood Glucose Meter press and hold the Main button for 3 seconds yS a TaT 3 Auto Power off The GE100 Blood Glucose Meter will power off automatically after 2 minutes if no buttons are pressed or strip is inserted NOTE If you do no change any settings during Meter Set up for over 2 minutes the GE100 Blood Glucose Meter will leave setting mode and power off automatically 20 el Easily Handling the GE100 Test Strip Easily Handling the GE100 Test Strip How to handle the GE100 Blood Glucose Test Strip 1 4 T U Inserting the GE100 Blood Glucose Test Strip he gt Removing the GE100 Blood Glucose Test Strip ao 1 Hold the GE100 Blood Glucose Test Strip between your thumb and middle 1 Hold the GE100 Blood Glucose Test Strip as shown finger with indication symbol 3 facing up Ne 2 Put forefinger on2. Test Strips Discard 4 months after first opening Discard date _ 2009 10 01 Exp Date 2009 11 18 Lot No X10813A Control Solution Range LJ Alternative site testing palm or forearm blood sampling To do the alternative site testing install the clear cap for your GE100 Lancing Device For detailed information check the instruction manual for the GE Lancing Device To increase the blood flow massage the puncture area of your palm or forearm for a few seconds Immediately after massaging the puncture area press and hold the lancing device with the clear cap against your 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 Alternative Site Testing View Window Appearance CAUTION Test results may vary if blood samples are taken from different sites or under certain conditions when 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 rapid changes in glucose faster than palm or forearm samples
3. Acetaminophen Ibuprofen Methyldopa Salicylic Acid Tetracycline Tolbutamide Bilirubin unconjugated Cholesterol Creatinine Triglyceride Maltose xylose Galactose and Lactose when occurring in normal blood or normal therapeutic concentrations do not significantly affect results However abnormally high concentrations in blood may cause inaccurate results Sodium Fluoride Potassium Oxalate at low glucose levels may result in inaccurate blood glucose reading Sodium Fluoride Potassium Oxalate should not be used as an anticoagulant with this device 46 Measurement Technology Measurement Calibration Sample Minimum Sample Volume Measuring Range Test Time Memory Capacity Power Saving Operating Temperature Operating Relative Humidity Specifications Oxidase Electrochemical Sensor Plasma Capillary whole blood 1 0 microliters 20 600 mg dL 5 seconds 500 blood glucose test results with date and time Turns off automatically 2 minutes after last user action or press the _ button for 3 seconds 50 104 F 10 40 C 10 90 47 Specifications Hematocrit Power Supply Meter Battery Life Meter Dimensions Meter Weight Monitor Display Area Meter Storage Conditions Test Strip Storage Conditions 48 30 60 1 CR2032 battery About 1000 tests 98 mm x 46 mm x 17 5 mm 53 0 5g with battery LCD 32mmx53mm 14 140 F 10 60 C 39 86 F 4 30 C lt 90 relati
4. Code Error appears again you may be using asi the wrong test strip Please check to make sure you are using the GE 100 Test Strip Meter Malfunction If the GE100 Blood Glucose Meter will not turn on please follow the steps below 1 Open the battery cover and remove the battery 2 Wait for 5 minutes and reinsert the battery as described in Meter Activation and Battery change on page 16 1 7 The GE100 Blood Glucose Meter should work normally after finishing the above steps If not please contact GE Diabetes Customer Support Center by calling 1 866 613 7085 45 Limitations Store the GE100 Blood Glucose Test Strips in the original capped vial at temperatures between 39 F to 86 F 4 C to 30 C and relative humidity below 90 Do not freeze GE100 Blood Glucose Test Strips are designed for using with capillary whole blood samples Do not use serum or plasma samples Inaccurate test results may be obtained at altitudes greater than 10 000 feet 30048 meters above sea level Hematocrit below 30 may cause higher results and hematocrit above 60 may cause lower results Severe dehydration and excessive water loss may cause inaccurately low results GE100 Blood Glucose Monitoring System has not been validated for use on neonates Inaccurate test results may be obtained by abnormal concentrations of Uric acid 10 0 mg dL L Dopa 3 mg dL Dopamine 2 mg dL Ascorbic acid Vitamin C 5 mg dL NOTE
5. Consult your healthcare professionals before sampling from your palm or forearm Since the blood flow in the forearm is less than that in the fingertips or palm use the clear cap with the GE Lancing Device when testing on the forearm If you use the depth adjustable cap when testing on the forearm the blood sample may not large enough for the meter Periodically compare the test system to a laboratory test system that is known to be well maintained and monitored by a healthcare provider 30 Ouse Make sure your blood sample covers the whole area of the view window to get an accurate test result An insufficient blood sample will result in an error message Er4 If this occurs repeat the test with a new test strip A 4 A Insufficient blood sample Enough blood sample CAUTION Check the expiration date printed on the package every time you use the strip Do not use expired GE100 Blood Glucose Test Strips Use each GE100 Blood Glucose Test Strip immediately after taking it from the vial Do not reuse GE100 Blood Glucose Test Strips 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 51 Understanding Test Results and Messages Blood glucose test results are shown on the GE100 Blood Glucose Meter as mg dL If your blood g
6. on authorized NOTE Do not perform a blood glucose test when USB cable is connected to the Blood Glucose Meter GE softwa re only 10 11 The GE100 Blood Glucose Meter The GE100 Blood Glucose Meter mem NO AVG MeM indicates a test result stored in memory Indicates when to apply the blood sample Indicates a test result not included into the Average CS Zan mmo L NO AVG function of this meter Occurs when strip is not compatible with your meter AVG _ Indicates the average result CodeError o if a strip is e Aa Month Day Current date under time mode or testing date under CS Indicates a control solution test result a m memory mode mmol L Indicates if the environmental temperature limit is TIE cn mg dL ge ees D exceeded during testing g H g TMi l _ 1 Test result wiht Indicates the time in 12H format K EN mg dL I3 Warns when the battery is low or must be replaced Hea toe time mode or testing time under ChecK Ke ileal y c OK EN Check Key Manufacturing use only Code Error 2 Month Day rin Cer CIDI ier DI I Lk HAN Sooo EN AO Lees 12 13 The GE100 Blood Glucose Test Strip The GE100 Blood Glucose Test Strip The GE100 Blood Glucose Meter can only be used with the GE100 Blood Glucose Test Strips The use of other test strips or control solutions can lead to incorrect results N gt Electrode Cont
7. 0 Blood Glucose Monitoring System passes the Quality Control Test and your GE100 Blood Glucose Monitoring System is working correctly Control Solution Range Example of Control Solution Range est Strips Control Solution Range mg dL printed on your test strip vial label ma Normal 83 113 lt High 237 321 When should a Quality Control Test be performed To ensure that your GE100 Blood Glucose Meter and Test Strip are working properly To confirm that you are following the correct procedure To prepare for your initial blood glucose test To check the GE100 Blood Glucose Test Strip when you open a new vial of strips To check your GE100 Blood Glucose Meter after it has been dropped damaged or exposed to liquids If you suspect that your test results are inaccurate or if your test results are not consistent with the way you feel 54 J NOTE If you want to purchase new normal or high level GE100 Control Solutions please contact customer service Possible reasons your Control Solution results are out of range Your GE100 Control Solution is expired or was opened more than 3 months ago Your GE100 Blood Glucose Test Strips have expired You left the cap of the GE100 Blood Glucose Test Strip vial or the GE100 Control Solution off for a period of time You didn t perform the test procedure correctly Malfunction of the GE100 Blood Glucose Meter or Test Strip If control solution test results a
8. GE Diabetes Customer Support Center 1450 E Spruce Street Bldg B Ontario CA91761 USA Copyright 2011 Bionime Corporation All Rights Reserved Worldwide 3 Caution Precaution Before using the GE100 Blood Glucose Monitoring System to test your blood glucose please read all the instructions and conduct all the tests including the quality control test Refer to page 36 Please do the quality control test regularly to make sure the test results are accurate The GE100 Blood Glucose Meter can only be used with the GE100 Blood Glucose Test Strips Other brand strips should not be used under any circumstances The use of other brands of strips may give inaccurate results The GE100 Blood Glucose Monitoring System is intended for in vitro diagnostic use only The testing result is calibrated to be plasma equivalent to testing with fresh capillary whole blood samples from the fingertip palm and forearm The GE100 Blood Glucose Monitoring System is intended for self testing and professional use It should not be used to diagnose diabetes mellitus GE100 Blood Glucose Monitoring System has not been validated for use on neonates Therefore it s not intended for use on neonates GE100 Blood Glucose Monitoring System has not been used for arterial blood testing yet so it is not Suitable to be used for arterial blood testing If the GE100 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperatu
9. Insulin Medication Other Blood Glucose Bedtime Blood Glucose Insulin Medication Insulin Medication Comments Other Blood Glucose Insulin Medication 64 Comments 65 Warranty Card Distributor name and address PLACE STAMP HERE 67 Warranty Card Name Tel Distributor name and address Address Serial No Model Date of purchase Please present this card for product replacement Limited warranty 1 Warrants the original purchaser only that the GE100 Blood Glucose Meter shall be free of any defects in materials or 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 Guarantees the performance of the GE100 Blood Glucose Meter only if used as directed and provided that the failure to perform has not been caused in whole or in part by the use of test strips that are not GE100 Test Strips Use only GE100 Blood Glucose Test Strips in your GE100 Blood Glucose Meter 3 The sole obligation of this warranty shall be to replace any defective GE100 Blood Glucose Meter No other warranties express or implied are made Not responsible for any incidental or consequential damages 4 You must contact your distributor for assistance and or in
10. Preface Preface Thank you for selecting the GE100 Blood Glucose Monitoring System This manual provides all the information you need to operate this product for accurate test results Please read the entire manual before you start any testing For people living with diabetes it is important to regularly monitor blood glucose levels to effectively reduce complications from the disease The easy to use GE100 Blood Glucose Monitoring System provides accurate reliable results to help you better manage your diabetes The GE100 Blood Glucose Monitoring System is perfect for both self testing and professional use Designed for in vitro diagnostic use only testing requires just a small amount of fresh capillary whole blood from either the fingertip palm or forearm If you have any questions regarding the GE100 Blood Glucose Monitoring System or testing procedures contact our Customer Support staff or your healthcare professional The GE100 Blood Glucose Monitoring System is manufactured and supported by Bionime Corporation and its authorized representative If you have any questions or concerns please contact GE Diabetes Customer Support Center toll free at 1 866 613 7085 or visit our website at www gediabetes com We will make every effort to provide assistance and solutions for you A Healthcare professional should be contacted when Customer Service is not available Please forward your warranty card to GE Diabetes Customer Support Center
11. a Blood Glucose Test Performing a Blood Glucose Test 6 Choose a depth of penetration by rotating the top portion of the depth 11 A blood drop icon will appear on the display window and will 11 adjustable cap until your desired depth setting is visible in the window be accompanied by a beep if volume is turned on Apply ve Settings are based on skin type for soft or thin skin D for the blood sample within 2 minutes ce average skin m for thick or calloused skin 7 Hold the base in one hand and pull on the plunger with the 12 Place the lancing device against your fingertip and press the other hand The device will be cocked Release the plunger release button and it will automatically move back to its original position 5 ae near the base R 13 Touch and hold the drop to the edge of the sample port until 8 Wash your hands with warm soapy water and dry thoroughly 9 Take one GE100 Blood Glucose Test Strip from the vial Close the vial cap immediately 10 Insert the strip into the Test Strip Port of the GE100 Blood Glucose Meter with the indication symbol facing up The meter confirms the insertion of the strip with a beep if volume is turned on NOTE The GE100 Blood Glucose Meter will automatically detect the Code number on the strip You don t have to check the Code number on the meter display or strip vial you hear a beep if volume is turned on and the view wi
12. acts Sensing signal output terminals Sample Port Sample Entry 5 Apply blood Control Solution here U CAUTION d Hodier toreni Close the GE100 Blood Glucose Test Strip vial immediately after taking out a test strip Noble Metal Breer ay C K isteir inta meter Do not reuse GE100 Blood Glucose Test Strips Electrochemical sensor e Do not use expired GE100 Blood Glucose Test Strips When you open a new vial of GE100 Test Strips record the date on the vial Discard the vial of test strips after 3 months from opening Insertion Symbol Mew Window Store GE100 Blood Glucose Test Strips in a cool 39 86 F or 4 30 C and dry location lt 90 relative humidity Do not expose to direct sunlight or heat For detailed information please refer to the GE100 Blood Glucose Test Strip Package Insert If the GE100 Blood Glucose Meter and Test Strips are exposed to a substantial change in temperature please wait 30 minutes before measurement 14 15 Meter Activation and Battery change Meter Activation and Battery change Your GE100 Blood Glucose Meter comes with one CR2032 3volt battery installed One new battery will provide power to perform about 1000 tests under normal use Press the main button or insert a strip to activate your meter lt v N XR XR Xi 1 Turn the GE100 Blood Glucose 2 Install the battery Be sure to put 3 Slide the batte
13. appear 2 Month setting With the month blinking press the Up or Down button until you see the current month Press the Main button to confirm Once the month is confirmed the Day setting will flash 3 Day setting With the day blinking press the Up or Down button until you see the current day Press the Main button to confirm Once the day is confirmed the Time setting will flash 18 oF Month Day Z ot 4 a of x IUL cw A N I a L AILI w Setting Up Your Meter Setting the Time Volume and Date 4 Time format 12 24H selection With the time format blinking press the Up or Down button to switch between 12H and 24H Press the Main button to confirm your hour setting Once confirmed the hour setting will flash 5 Hour setting With the hour blinking press the Up or Down button until you see the current hour Press the Main button to confirm Once the hour is confirmed the minute setting will flash 6 Minute setting With the minute blinking press the Up or Down button until you see the current minute Press the Main button to confirm Once the minute is confirmed the volume setting will flash 7 Volume setting With the volume blinking press the Up or Down button to turn it on or off Press the Main button to confirm and finish the settings 4a N Month h Ke j f 4b ILI j Le 5 7 L Month i Day x cr
14. ccurate test result perform testing between 50 104 F 10 40 C 1 When the ambient temperature is 32 48 F 0 9 C or 106 122 F 41 50 C the warning symbol will blink 1a You can still do the test but the test result may not be reliable Tests in the memory screen this value will be flagged with lt symbol 1b Repeat the test in an area with temperature ranges between operating range 50 104 F or 10 40 C 2 When you move from an area with temperature outside the operating range to another area with temperature inside operating range please wait for 30 minutes before you test 3 When the temperature is below 32 F 0 C or over 122 F 50 C the GE100 Blood Glucose Meter will blink the Error symbol with the thermometer symbol displaying on screen 44 Error Messages and Troubleshooting cr Sampling Error Do not apply the blood drop to the sample entry of the strip before the GE100 Blood Glucose Meter displays If you do so the meter will display Error and ee accompanied by beeps if volume is turned on Please discard the test strip and Error repeat the test with a new GE100 Blood Glucose Test Strip Code Error When a test strip is not inserted correctly Code Error will flash on the screen Please reinsert the strip following the instructions on page 26 Performing a Blood Glucose a Test If after following the instructions
15. complies with In Vitro Diagnostic Medical Device Directive 98 79 EC CE0197 Name sad ct Et ac ee ac a cent haart cman arlene enabler dinar octet ccna ben ht di ev tae eres canada Primate ATE acdc a dude neem Address GE100 Lancing Device aR tek i ii aa ir cma aie Rb Se Gb i iit ih en ti Manufacturer Bionime Corporation Home Phone Work Phone Product complies with Medical Device Directive 93 42 EC UNEA AA chee tench ca ace ce eee ce ake ceased ees ta ae cats EA AA eae cages te eee ee cco gees E ge pete seca ete fe A I AA Mea aces hee pe eesti Doctor Doctor s Phone Disposable Sterile Lancets Manufacturer SteriLance Medical Suzhou Inc Pharmacy Pharmacy Phone POeCCORIGIGSUNMISMIGGIDEUOISANCOSED ECC OIogD L ene cee E a 52 E Log Book Log Book DATE DATE S Blood Blood Breakfast ou Breakfast CICOS Insulin Insulin Medication Medication Blood Blood Lunch a Lunch a Insulin Insulin Medication Medication Blood Blood Glucose l Glucose Dinner Dinner Insulin Insulin Medication Medication a e l G l G Bedtime 2 Bedtime a Insulin Insulin Medication Medication Blood Blood Other S Other d Insulin Insulin Medication Medication Comments Comments 54 55 Lo
16. cose values You will see the number of the calculated days in the lower left corner and the number of the calculated readings in the lower right corner 38 Recalling Test Results and Average AVG AVG AVG AVG AVG imme mmo Tain 6m mN wg mo wo tiu tug J WGN Non Averaging set and canceled You may exclude unwanted or doubtful test results from the average calculation After you finished your test in the test mode you can exclude the unwanted result Keep pressing the Down button until you see the symbol NO AVG in the top right corner of the screen Press the Down button and the Main button simultaneously to confirm the value as Non average This value is flagged by the symbol NO AVG in the upper right corner of the screen To cancel a non averaging setting keep pressing the Down button until the NO AVG symbol changes to AVG in the upper right corner of the screen To confirm this original status simultaneously press the Main button to confirm the AVG status The value will be stored as a regular value and included in the average values yyy NOTE The average function requires that the correct time and date is set If the time and date are not set correctly the average function will not be correct The Non averaging re averaging function only works in test mode and when you get a value This action cannot be performed in MEM mode 39 Recalling Test Results and A
17. dentify each item learn 1 2 5 its name and how it is used ee onio ing 6 Below are the items included in your GE100 Blood Glucose Monitoring System ie E100 1 Getting Started Guide 2 User s Manual includes Log Book Warranty Card amp Emergency Card 6 gt 10 3 GE100 Blood Glucose Test Strip Package Insert 4 GE100 Control Solution Package Insert 5 GE100 Blood Glucose Meter with 1 CR2032 batteries installed 6 GE100 Blood Glucose Test Strips 0 10 25 pcs 7 GE100 Control Solution 8 GE Lancing Device 9 Clear Cap 10 Disposable Sterile Lancets 10 pcs 11 Carrying Case not shown 12 Instructions For The Lancing Device not shown Different packages have different bundled items Some of packages might not include gt items GE Lancet Iy dispose lancet immediately ater use The GE100 Blood Glucose Meter The GE100 Blood Glucose Meter Test Strip Port 5 qT yy Tt T T D GE100 Up Button Down Button ooood ff ggg dd va f D Battery Cover Display Window a GE100 H Product name Dao Meter Battery LL an Main Button en Ne J USB Port L J For data downloading
18. dication Insulin Medication Other Blood Glucose Bedtime Blood Glucose Insulin Medication Insulin Medication Comments Other Blood Glucose Insulin Medication 60 Comments 61 Log Book Log Book DATE Breakfast Blood Glucose DATE Insulin Medication Lunch Blood Glucose Breakfast Blood Glucose Insulin Medication Insulin Medication Dinner Blood Glucose Lunch Blood Glucose Insulin Medication Insulin Medication Bedtime Blood Glucose Dinner Blood Glucose Insulin Medication Insulin Medication Other Blood Glucose Bedtime Blood Glucose Insulin Medication Insulin Medication Comments Other Blood Glucose Insulin Medication 62 Comments 63 Log Book Log Book DATE Breakfast Blood Glucose DATE Insulin Medication Lunch Blood Glucose Breakfast Blood Glucose Insulin Medication Insulin Medication Dinner Blood Glucose Lunch Blood Glucose Insulin Medication Insulin Medication Bedtime Blood Glucose Dinner Blood Glucose Insulin Medication
19. from the top of the cap The screen will display the count time starting from 5 you will hear a beep if the volume is turned on Performing a Quality Control Test 9 Tightly replace the cap on the GE100 Control Solution bottle 10 The Control Solution result will appear Compare your Quality Control Test result to the Control Solution Range printed on the GE100 Blood Glucose Test Strip vial label CAUTION A Your Control Solution Test results will not be included in the Average calculations however they can still be recalled and viewed The Control Solution Test result will be shown with CS symbol on the screen Control Solution Test should be conducted between 59 104 F 15 40 C Before jw and es appears do not touch the GE100 Control Solution to the sample entry on the strip The GE100 Blood Glucose Meter is preforming an internal check touching the Control Solution to the sample entry before prompted will result in an error message Error and and be accompanied by beeps if volume is turned on Don t drip the GE100 Control Solution into the sample port of the strip directly T2 the strip might leak into the bottle of GE100 Control Solution and may cause the degeneration of GE100 Control Solution Doing this could also contaminate the meter via the test strip port Don t touch the tip of the GE100 Control Solu
20. g Book Log Book DATE DATE S Blood Blood Breakfast oc Breakfast CICOS Insulin Insulin Medication Medication Blood Blood Lunch ene Lunch a Insulin Insulin Medication Medication Blood Blood Glucose l Glucose Dinner Dinner Insulin Insulin Medication Medication n e l G l G Bedtime es Bedtime Insulin Insulin Medication Medication Blood Blood Other ones Other pute Insulin Insulin Medication Medication Comments Comments 56 57 Log Book Log Book DATE DATE S Blood Blood Breakfast oc Breakfast CICOS Insulin Insulin Medication Medication Blood Blood Lunch ene Lunch a Insulin Insulin Medication Medication Blood Blood Glucose l Glucose Dinner Dinner Insulin Insulin Medication Medication n e l G l G Bedtime es Bedtime Insulin Insulin Medication Medication Blood Blood Other ones Other pute Insulin Insulin Medication Medication Comments Comments 58 59 Log Book Log Book DATE Breakfast Blood Glucose DATE Insulin Medication Lunch Blood Glucose Breakfast Blood Glucose Insulin Medication Insulin Medication Dinner Blood Glucose Lunch Blood Glucose Insulin Medication Insulin Medication Bedtime Blood Glucose Dinner Blood Glucose Insulin Me
21. lucose result is unusually high or low or if you question your test results repeat the test with a new GE100 Blood Glucose Test Strip You can also run a Quality Control Test with the GE100 Control Solutions to check your GE100 Blood Glucose Meter and Test Strip Refer to page 36 If the test result still remains unusually high or low contact your healthcare professional immediately If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all of the instructions in this manual contact your healthcare professional immediately 52 Understanding Test Results and Messages The GE100 Blood Glucose Meter displays results between 20 and 600 mg dL u D n If your test result s DSaW 20 mg dl Lo will appear on the screen Please L T repeat your test again with a new strip mg dL If you still get LO result you should immediately contact your healthcare professional If your test result is above 600 mg dL H will appear on the screen Please repeat your test again with a new strip If you still get Hr result you should immediately contact your healthcare professional 53 Quality Control Test Quality Control Test Use normal or high level GE100 Control Solutions when testing your GE100 Blood Glucose Monitoring System in the Control Solution Mode If the test result is within the Control Solution Range printed on the strip vial label your GE10
22. nd Battery CHOICE os ccasissssseassizascniapssasebansstsn vps inaserinsinaieiadbanda buasaiea ypeads tnasSeonssina oniaidinaielaapsteanencaisioatele 16 Setting Up Your Meter Setting the Time Volume and DOte nn cccecccscssssssssesssseessseessseesssecssssesssssssseesssecsssecssseessseesssessns 18 Tunmg nrg aida Shs 1k lt i eaeeenemee etter enn DeLee came TE EE T Re E oie ener ent Tm 21 Handling the GE100 Test Stri Gaessen AN 22 Testing Procedure Catina Reddy Tor TeS UNan AA RN A AAE AE 24 PS NI d a TeS encensa A N SEEE EA 25 Disaldy OF Ol OCS sessen n 31 Understanding Test Results and MOSS CS sss cosissssscasusscesscoiversaacesausen ocesl eronsuiesbsnem yceibdecesucsavsseocdbseronviesssamvcdivenaauesuestons 52 Quality Control Quality Control Test Performing a Quality Control Test Test Memory Recalling Test Results and Average Error Messages and Trouble Shooting Limitations Specifications Customer Service Expected Glucose Values Without Diabetes Essential Components List Warranty Card Emergency Card Caring or Your Meter cecsosooccoooooeoocosocococoocooososoososococosooocoocosooscoccososocococsosococosocococeosoosooccocsosososoososocscosooceoocosocsooccososocococsosococosococoososoososeoooo 11 The GE100 Blood Glucose Monitoring System The GE100 Blood Glucose Monitoring System Your GE100 Blood Glucose Monitoring System consists of several items Please i
23. ndow is filled with blood If the view window is not completely filled with blood the test will not start Refer to page 5 for Sample Size Chart Discard the test strip and repeat with a new GE100 Blood Glucose Test Strip i 14 Countdown mode will begin on the display window After 5 seconds your test result will appear 26 Performing a Blood Glucose Test Alternative Site Testing 15 Pull off the depth adjustable cap Without touching the used f disposable lancet insert the lancet tip into the protective cover 16 Hold the release button in one hand see picture 16 step 1 and pull on the plunger with the other hand see picture 16 step 2 to safely eject the used disposable lancet 17 Discard the used disposable lancet into an appropriate puncture proof or biohazard container 18 Replace the depth adjustable cap after finishing the test AN CAUTION Do not apply your blood drop to the sample port on the strip until you see the appear The GE100 Blood Glucose Meter is performing an internal test and will display and Error if you apply blood too soon Please repeat the test with a new GE100 Blood Glucose Test Strip Record the opening date of a new GE100 Blood Glucose Test Strip vial Discard the vial of test strips 3 months after opening 28
24. o not get the 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 that the GE100 Blood Glucose Meter is working properly 41 Error Messages and Troubleshooting Er1 The inserted test strip has been used or damaged Please use a new test strip from vial Z Z J LI I LIL Er2 First replace the battery see page 16 Meter Activation and Battery Change If Er2 appears after replacing the battery perform a perform a Quality Control Test see page 36 Performing a Quality Control Test oo C2 C u Er3 Signal transmission is disrupted repeat the test Le Le If the error messages continue after attempting to remedy please contact GE Diabetes Customer Support Center by calling 1 866 613 7085 42 Error Messages and Troubleshooting Battery Error 1 The a symbol blinks when the battery power is low Please change the battery as soon as possible You can still test 2 The C3 and Error symbols blink when the battery is too low Meter cannot test Please change the battery immediately la mem 1b 2 INE I Pe mg dL T ca ca Error ca ogi i i J 43 Error Messages and Troubleshooting Temperature Error In order to get an a
25. re please wait 30 minutes before measurement Follow all environmental protection regulations when disposing of batteries Do not perform a blood glucose test when USB cable is connected to the Blood Glucose Meter 4 Avoid contact with dripping or splashing liquids The minimum blood sample size to test using the GE100 Blood Glucose Monitoring System is 0 75uL 0 7 SUL Sul 2 0uL 3 0uL 4 0uL Sample Size Example A minimum of 0 75uL of blood is needed for testing with the GE100Blood Glucose Monitoring System Blood sample size above 3 0uL might contaminate the test strip port and the meter Blood sample size below 0 75uL might cause inaccurate test result or might not start the meter In this case repeat the test with a new test strip CAUTION The GE100 Blood Glucose Meter will be set to mg dL by default when sold in the United States When your display shows mmol L during setting or test please contact customer service Use of the wrong unit of measure may cause incorrect treatment Table of Contents Table of Contents About The GE100 System The GE100 Blood Glucose Monitoring SVSLSM isdiscssscestusraissnressiemeevaenssainaddauneaantenusd A NAE 8 The GE100 Blogd Glucose Meta susini a A 10 The GE100 Blood Glucose Test Str Po ceecceesssessssessssessssessssessssessssesssusssssscssssssssssssussssussssuscssussssuscssuscssuecssuccssuecssuecssueessueesseeesses 14 Before Testing Meter Activation a
26. re out of range your GE100 Blood Glucose Monitoring System may not be working properly Repeat the quality control test If your control Solution results outside the range still exist do not do not use the GE100 Blood Glucose Monitoring System to test your blood glucose and contact GE Diabetes Customer Support Center by calling 1 866 613 7085 Example of Expiration Date N CAUTION xampie of Expiration Vate Each time you open a new bottle of GE100 Control Solution write the expiration date on the label GE100 Control Solution is good for 3 months after opening the bottle or until the expiration date printed on the label whichever comes first Exp Date 2012 06 55 Performing a Quality Control Test 1 36 Take one GE100 Blood Glucose Test Strip from the vial and close the vial cap immediately Insert the GE100 Blood Glucose Test Strip with the window facing up into test strip port While the blood drop icon is flashing on the display window press and hold the Main button for at least 3 seconds until the CS symbol appears You will see the blinking icon and CS icon on the screen prompting you to the apply GE100 Control Solution Shake the bottle of GE100 Control Solution well before opening the cap Place the cap on a flat surface Place a drop of the control solution onto the top of the cap Gently touch the sample entry of the strip with the GE100 Control Solution
27. ry cover Meter over Press and slide battery in correct direction back until it snaps into battery cover to open polarity facing up place 4 The Meter will enter self tesing mode automatically when replacing the battery all symbols will show on the screen 5 Press any button to enter the Setting Mode 6 You must set the time and date when replacing the battery See Chapter Setting Up Your Meter Setting the Time Volume and Date Test results are still stored in the memory CAUTION Please follow the local regulation and discard a used battery properly 16 You can enter Setting Mode two ways 1 Replace 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 GE100 Blood Glucose Meter performs a self test Press the main button to exit the self test and enter Setting Mode 2 With Battery Inserted Press the main button first to turn on the GE100 Blood Glucose Meter Hold down the main button for 7 Seconds During this time the screen will go blank and then after hearing a beep it will turn on into Setting Mode The display screen will show setting data 17 Setting Up Your Meter Setting the Time Volume and Date 1 Year setting With the year format blinking press the Up or Down button until you see the current year Press the Main button to confirm Once the year is confirmed the Month setting will
28. structions for obtaining a replacement GE100 Blood Glucose Meter N 68 Emergency Card EMERGENCY CARD GE100 Blood Glucose Monitoring System e User Name eEmergency Contact Phone No e Blood Type e Doctor Hospital am a diabetes patient If you find me in a coma or stupor please contact nearest emergency services immediately Or call Please fill out this card and carry with you at all times
29. the side of strip as shown E 2 Rotate the GE100 Blood Glucose Test Strip counterclockwise and pull up T S K simultaneously Rotate lt 2z P v M1 e S ey S J E o 3 Take the GE100 Blood Glucose Test Strip out of the test strip port Please follow 3 Insert the GE100 Blood Glucose Test Strip into test strip port until it clicks and 3 your local regulations and discard used strips properly firmly stops WS cn 8 NOTE Test Strip Port will not be contaminated by blood if you follow the steps correctly 22 23 Getting Ready for Testing Performing a Blood Glucose Test Before performing a blood glucose test prepare the items below GE100 Blood Glucose Meter GE100 Blood Glucose Test Strips Please check expiration date of test strips Do not used expired test strips GE100 Lancing Device Sterile lancet Alcohol swab optional 24 i Safe switch Hub aa 1 Hold the depth adjustable cap in one hand and hold the base with the other hand Bend the cap down When a gap appears between the cap and base pull them off in opposite directions 2 Pull off the depth adjustable cap 3 Insert a new disposable lancet firmly into lancet carrier 4 Twist off and set aside the protective cover of the disposable lancet 5 Replace the depth adjustable cap 25 Performing
30. tion bottle If you have touched Sf Recalling Test Results and Average The GE100 Blood Glucose Meter is able to automatically store a maximum of 500 test results with time and date If your meter has stored 500 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 the Memory screen You will see the MEM symbol in the upper left corner of the display When you press the Down button the latest result will be displayed By pressing the Down button sequentially previous test results will be shown in chronological order You will see the sequence number in the lower right corner and the year in the lower left corner of the display followed by date and time of the measurement Note The Up button is for reviewing the tests with the sequence number increasing and the Down button is for reviewing tests with sequence number decreasing The sequence 1 is the latest result while sequence 500 is the oldest test result 2 To finish reviewing stored test results press the Main button again This will bring you to the Average screen By pressing the Down button the display shows AVG in the upper right corner of the display and the average value for the day By pressing the Up or Down button you will get to the 1 day 7 days 14 days 30 days and 90 days average of your blood glu
31. ve humidity Warranty 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 GE100 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 GE100 Blood Glucose Meter Please complete and return the enclosed warranty card Different models have different specifications This warranty applies only to the GE100 Blood Glucose Monitoring System other models are not covered with this warranty card 49 Customer Service Expected glucose values without diabetes Please review all the instructions to make sure you are performing the steps correctly If you have any Expected glucose values without diabetes questions or concerns please contact us toll free at 1 866 613 7085 Monday through Friday 8 00 AM to 5 00 PM PST or visit our web site www gediabetes com We will make every effort to provide assistance and solutions for you Range mg dL Fasting eee References 1 Diabetes Information American Association for Clinical Chemistry AACC Electronic Version Retrieved June 15 2010 from www labtestsonline org understanding analytes glucose test html 50 51 Essential Components List Log Book GE100 Blood Glucose Meter Test Strip and Control Solution Manufacturer Bionime Corporation Product
32. verage 4 Quick Searching If you want to see all values automatically displayed in sequence enter the memory mode Press and hold the Up or Down button for 2 seconds Down button is for searching the latest test value to the oldest one Up button scrolls from the oldest to the latest one Anytime you want to stop just release the pressed button It will stop and display the current value Use this to check a particular reading Most Current Test Result Press the Main button to enter the MEM memory screen and review the latest test result Og J NOTE Control Solution Test results are not included in the Average calculations but they can be recalled and viewed The Control Solution Test results will show with CS symbol under memory screen CAUTION You have to set the time and date to activate the average function The L o and H results the control solution results and the test results measured when the meter was outside of its operating temperature range will not be included in the average 40 Caring tor Your Meter Maintenance Keep your GE100 Blood Glucose Meter and Test Strip free of dust water or any other liquid Store the meter in the carrying case when not in use If meter is dropped or damaged perform a quality control test with the control solution before doing a blood glucose test Cleaning Meter Clean the outside of the GE100 Blood Glucose Meter with a damp cloth and mild soap detergent D
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