ApexBio GlucoSure Autocode, Manual

Page 1: ...d it care fully Your GlucoSure Autocode Blood Glucose Monitoring System provides an easy and precise way to measure blood glucose using fresh capillary whole blood taken from fingertips palm or forearm Testing is done outside the body in vitro diagnostic use The test results are plasma calibrated for easy comparison to lab results The GlucoSure Autocode Blood Glucose Monitoring System is a portabl...

Page 2: ... as an aid to monitoring levels in Diabetes Mellitus It is not in intended for the diagnosis or screening of diabetes or for neonatal use IMPORTANT Dehydration Severe dehydration may lead to inaccurate blood glucose test result If you suspect you are severely dehydrated contact your healthcare professional immediately Hematocrit range A hematocrit range that is higher than 55 or lower than 30 can ...

Page 3: ...est Strip 10 Setting Up Your New System Inserting or Changing the Battery 11 Setting the Clock 13 Setting the Alarm 17 Turning ON OFF Beep Sound 19 Control Solution Testing Performing a Control Solution Test 21 Control Solution Trouble Shooting 27 Testing Your Blood Glucose Preparing Your Lancing Device 29 Blood Glucose Monitoring System 3 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM P...

Page 4: ...t a High or Low Reading 38 Viewing Stored Readings and 7 14 30 Day Average from Memory 40 Caring for the Meter Cleaning the Meter 44 Storage and Precautions 44 Solving Problems 46 Product Warranty 49 Specifications 50 Symbols Used in this Manual 52 Supplies 53 Blood Glucose Monitoring System 4 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM Page 4 ...

Page 5: ...t of the GlucoSure Autocode may include the following items Note Contents may change without notice Blood Glucose Monitoring System 5 The GlucoSure Au tocode Blood Glu cose Test Strips The GlucoSure Autocode Meter Lancing Device Log Book User Guide Wallet GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM Page 5 ...

Page 6: ...onds to turn the Meter on or off or press Enter to go into setup mode when not testing Press or to enter control mode with test strip inserted dur ing meter setting or to navigate the stored test values and aver ages T Te es st t S St tr ri ip p P Po or rt t This is where you insert the test strip and the meter will turn on automatically GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM Pag...

Page 7: ...ection Port This function is not yet available Blood Glucose Monitoring System 7 Battery Compartment Holds one CR 2032 3V Lithium coin cell battery GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM Page 7 ...

Page 8: ...Glucose Monitoring System 8 ctlmmgl dL AM DAY AVG PM mem BEEPER MAIN DISPLAY AREA UNIT MEMORY BATTERY TEMPERATURE TEST STRIP Blood DROP DAY AVERAGE MINUTES HAPPY SAD FACE ALARM CLOCK HOUR GS Autocode 1A manual CE 711 BK white 2011 10 12 1 44 PM Page 8 ...

Page 9: ...lash to prompt you to insert a test strip for testing DAY AVEARGE Displayed when viewing 7 14 or 30 day averages on page 40 UNIT Unit of Measurement for your blood glucose CTRL This icon indicates a control solution test on page 21 BEEPER Indicates the beeper is on on page 19 ALARM CLOCK Indicates the alarm function is turned on HAPPY FACE These icons indicate the meter electronic is working prope...

Page 10: ...st Strip with the GlucoSure Autocode Blood Glucose Meter Other brands of test strips will not work with the meter The GlucoSure Autocode Blood Glucose Test Strips are sensitive to moisture and light it is important to close the vial cap of the test strip bottle tightly after each use DO NOT leave any test strips outside the bottle while not in use Carefully discard used test strips and lancets in ...

Page 11: ...n ne ee ed d One CR 2032 3V Lithium coin cell battery Your GlucoSure Autocode Meter S St te ep p 1 1 Press firmly on the battery cover and slide in the direction of the arrow to open the cover Blood Glucose Monitoring System 11 ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM ctl mg dL AM c mg dL AM AM AM AM mg dL mmgl dL mmgl dL mg dL AM mg dL mg dL mg dL DAY AVG mg dL DAY ...

Page 12: ...ompts you to check the time and date when turned on either by a Test Strip or pressing If it is correct press again to exit or if the time and date are not correct on page 13 for Setting the Clock The date and stored results will not be erased when the batteries are being changed Discard used batteries according to your local regulation Blood Glucose Monitoring System 12 GS Autocode 1A manual CE 7...

Page 13: ...If error messages Err1 Err 3 etc appears see Solving Problems on page 46 S St te ep p 3 3 After a flashing test strip icon appears on the meter display screen press twice until meter display screen shows Blood Glucose Monitoring System 13 ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM AM AM mg dL AM ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM mg...

Page 14: ...ice and to advance to set the day Set Day S St te ep p 6 6 The current day will flash Use the or buttons to select the correct day Press to confirm your choice and to advance to set the 12 hour or 24 hour time format Blood Glucose Monitoring System 14 mg dL AM ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM AM mg dL AM mg dL AM mg dL AM ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY...

Page 15: ... to set the minutes Set Minutes S St te ep p 9 9 The current minutes will flash Use the or buttons to select the correct minutes Press to confirm your choice and exit time set up Blood Glucose Monitoring System 15 AM AM mg dL AM mg dL AM mg dL AM mg dL DAY AVG ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM AM AM mg dL AM mg dL AM mg dL AM mg dL DAY AVG ctlmmgl dL AM DAY AV...

Page 16: ... The changes you have done so far will be memorized by the meter Begin testing see page 28 Testing your Blood Glucose or press and hold to turn off the meter or see the next section on how to turn on or off the beeper Blood Glucose Monitoring System 16 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 45 PM Page 16 ...

Page 17: ... Solving Problems on page 46 Step 3 After a flashing test strip icon appears on the meter display screen press three times until flashes Blood Glucose Monitoring System 17 ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM AM AM mg dL AM ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM AM AM mg dL AM GS Autocode 1A manual CE 711 BK white 2011 10 12 1 45 ...

Page 18: ...t the correct alarm hour Press to confirm your choice and to advance to set the alarm minutes The alarm min Blood Glucose Monitoring System 18 ctlmmgl dL AM DAY AVG PM ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM ctl mg dL AM mg dL AM AM AM mg dL mmgl dL mg dL AM mg dL AM mg dL AM mg dL DAY AVG mg dL DAY AVG mg dL DAY AVG ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM ctl mg...

Page 19: ...ssages S St te ep p 1 1 Press button to confirm your choice to advance to turning the beeper on or off Step 2 Use the or buttons until meter display screen shows and the beeper ON OFF icon will flash Blood Glucose Monitoring System 19 ctlmmgl dL AM DAY AVG PM ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM ctl mg dL AM mg dL AM AM AM mg dL mmgl dL mg dL AM mg dL AM mg dL AM mg dL DAY AVG mg dL DAY AVG ...

Page 20: ... or insert a GlucoSure Autocode Test Strip and begin testing The changes you have done so far will be memorized by the meter Begin testing by inserting a GlucoSure Autocode Test Strip see page 28 Testing Your Blood Glucose or press to return to the start of set up or press and hold button to turn off the meter Blood Glucose Monitoring System 20 mg dL AM mg dL AM GS Autocode 1A manual CE 711 BK whi...

Page 21: ...ontrol solution testing when Using the Meter for the first time You open a new bottle of GlucoSure Autocode Blood Glucose Test Strips You left the cap on the test strip vial open for a while You dropped the Meter You suspect your GlucoSure Autocode Meter and GlucoSure Autocode Test Strips are not working properly The blood glucose test results do not reflect how you feel You want to practice the t...

Page 22: ...utions at room temperature 15 C 30 C 59 F 86 F M Ma at te er ri ia al ls s y yo ou u w wi il ll l n ne ee ed d Contrex Plus III Glucose Control Solution L1 and L2 Your GlucoSure Autocode Meter A new GlucoSure Autocode Blood Glucose Test Strip S St te ep p 1 1 Insert a GlucoSure Autocode Blood Glucose Test Strip into the meter with the blood sample reaction zone facing up Make sure the test strip c...

Page 23: ...st strip bottle label when you first open it Six months after first opened date discard the bottle and any remaining Test Strip Make sure you are testing in an environment that is between 10 C 40 C 50 F 104 F and allow 10 to 15 minutes for it to reach the new temperature before use Your meter will not begin testing if it detects it is outside this temperature range This is an auto coding meter You...

Page 24: ... L2 will appear next to the test strip icon on the meter display screen indicating that the meter is in Control Solution Testing If you decide not to do a control solution testing press the or button until the c ct tl l disappear from the meter display S St te ep p 5 5 Squeeze a drop of Glucose Control Solution L1or L2 onto a clean dry non absorbent Blood Glucose Monitoring System 24 ctlmmgl dL AM...

Page 25: ...r 6 seconds the control solution testing result will appear on the meter display screen S St te ep p 8 8 Compare the reading on the screen to the control range printed on the test strip bottle or its package If the reading does not fall within the control range printed on the test strip bottle or its package see Control Solution Trouble Shooting on page 27 Blood Glucose Monitoring System 25 ctlmmg...

Page 26: ...ulating averages Replace the bottle cap on the control solution bottle immediately after use Step 8 Manually remove the used test strip and discard it into a proper waste basket The meter will time out after 1 5 minutes of inactivity IMPORTANT Do not reuse test strips Blood Glucose Monitoring System 26 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 45 PM Page 26 ...

Page 27: ...Control solution not at room temperature Make sure you are using Contrex Plus III Glucose Control Solution L1and L2 Make sure the testing environment is between 10 C 40 C 50 F 104 F Check the expiration and open bottle date on both Control Solution and test strips Repeat the test using a new test strip If the result is still out of range use a new bottle of control solution and retest Please call ...

Page 28: ...rly and run a control test See Setting Up Your New System on page 11 and Control Solution Testing on page 21 for details Wash your hands and testing site thoroughly with soap plus warm water and dry well You are testing in an area between the temperature ranges of 10 C 40 C 50 F 104 F Your meter will not test outside of this range and will display Move the meter into an area that is between 10 C 4...

Page 29: ...Twist the adjustable cover back clockwise onto the lancing device NOTE For fingertip testing use the blue adjustable cap For alternate site testing on palm and forearm use the clear adjustable cap S St te ep p 3 3 Adjust the puncture setting on the adjustable cap for the puncture depth level 1 is the lightest and 5 is the deepest Blood Glucose Monitoring System 29 GS Autocode 1A manual CE 711 BK w...

Page 30: ...for blood sampling IMPORTANT Use a new sterile lancet every time you test to avoid cross contamination If alcohol wipes are used to cleanse the fingers make sure the area is dry before the blood sample is ob tained The lancets are for single used only Do not reuse lancet Blood Glucose Monitoring System 30 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 46 PM Page 30 ...

Page 31: ...fingertip and palm and forearm 1 AST re sult may be significantly different than results from finger tip testing under certain conditions You should consult with your doctor or healthcare professional before using AST D DO O A AS ST T O ON NL LY Y i in n t th he e f fo ol ll lo ow wi in ng g i in nt te er rv va al ls s In a pre meal or fasting state more than 2 hours since last meal 2 hours or mor...

Page 32: ...t match the way you feel You are testing for hyperglycemia Your routine glucose results are often fluctuating If you are pregnant Consult with your healthcare professional to decide if AST is right for you NOTE If results from AST do not agree with how you feel use fingertip testing instead 1 Jungheim K Koschinsky T Risky delay of hypoglycemia detection by glucose monitoring at the arm Diabetes Ca...

Page 33: ...ng it from the bottle Do not use wet or damaged test strips Keep away from direct sunlight and heat Store the test strip bottle in a dry cool place Record the date opened on the bottle label Discard the bottle and any remaining test strip after six months from date of opening Insufficient blood specimen may cause incorrect results Must insert test strip to the bottom Must see a flashing blood drop...

Page 34: ...te a puncture TIP Gently massage your hand and finger toward the puncture site to form a drop of blood approximately Do not milk or squeeze around the puncture site Lance the side of your fingertip to avoid soreness To avoid calluses choose a different lancing site each time Blood Glucose Monitoring System 34 ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM mg dL AM ctl mg dL AM mg d...

Page 35: ...button Do not lift up For forearm test sites apply and release pressure Pumping for a few seconds while keeping the lancing device in constant con tact with the skin Palm testing at the base of the thumb does not require pumping When the blood is about the size of a pen tip approximately lift the lancing device straight up without smearing the blood IMPORTANT If results from AST do not agree with ...

Page 36: ...er 6 seconds your glucose testing result will appear on the meter display screen Your test result will be automatically stored into the meter memory CAUTION If you see HI or LO displayed your blood glucose level may be above 600 mg dL or below 20 mg dL Test again using fingertip testing DO NOT test on palm or forearm If you still receive the same result call your physician or healthcare profession...

Page 37: ...sed lancet from your lancing device according to instructions and discard into proper wastebasket IMPORTANT Used lancets and strips are biohazard materials and can transmit bloodborn disease Dis pose them according to local government regulations to avoid injury or contamination Blood Glucose Monitoring System 37 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 46 PM Page 37 ...

Page 38: ...is more than 250 mg dL or below 50 mg dL AND you feel ill Blood Glucose Monitoring System 38 N No or rm ma al l a an nd d T Ta ar rg ge et t B Bl lo oo od d G Gl lu uc co os se e R Ra an ng ge es s N No or rm ma al l B Bl lo oo od d G Gl lu uc co os se e L Le ev ve el ls s i in n P Pe eo op pl le e W Wh ho o D Do o N No ot t H Ha av ve e D Di ia ab be et te es s Upon waking fasting 70 to 100 mg dL...

Page 39: ...ill get a high or low reading contact your healthcare professional IMPORTANT Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperos molar state with or without ketosis Critically ill patients should not be tested with blood glucose meters Reference 1 American Diabetes Association St...

Page 40: ...better track your effort in controlling your blood glucose level You will need to set your meter date and time before using the memory and day averaging function see page 11 Setting Up Your New System The meter will not memorize any test or control results if the date and time are not set M Ma at te er ri ia al l y yo ou u w wi il ll l n ne ee ed d Your GlucoSure Autocode Meter S St te ep p 1 1 Tu...

Page 41: ...e mem will appear at the upper left corner of the display screen Press to select the mem mode S St te ep p 4 4 Press to view your result from the most recent to the oldest When less than 300 results are stored in the meter s memory nil will appear after the last recorded test result Blood Glucose Monitoring System 41 ctlmmgl dL AM DAY AVG PM mem ctlmmgl dL AM DAY AVG PM mg dL AM AM mg dL AM mg dL ...

Page 42: ...in the meter the display screen will show nil When there are no day average data available the display screen will show 4 dashes Blood Glucose Monitoring System 42 mg dL mg dL AM mg dL AM mg dL DAY AVG mg dL DAY AVG AM PM AM PM AM AM AM AM mg dL AM AM AM AM AM mg dL mmgl dL mmgl dL mmgl dL mg dL AM mg dL AM mg dL AM mg dL AM mg dL mg dL mg dL DAY AVG mg dL DAY AVG mg dL DAY AVG mg dL DAY AVG ctlmm...

Page 43: ...ll not be erased when changing batteries After you finish viewing memory or days averages either begin testing by inserting a Glu coSure Autocode Blood Glucose Test Strip see page 28 Testing Your Blood Glucose or press and hold the button to turn off the meter Blood Glucose Monitoring System 43 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 46 PM Page 43 ...

Page 44: ...gent Do not get water inside the GlucoSure Autocode Meter Never immerse the meter or hold it under running water Do not use glass or household cleaners on the meter Do not try to clean the test strip holder Do not contaminate the strip holder with blood or control solution Storage and Precautions Handle the meter with care severe shock such as dropping the meter could damage the electronics Blood ...

Page 45: ...ke sure it is closed tightly Do not take the meter apart Doing so will void the warranty Do not use this meter in a dry environment especially if synthetic materials are present Synthetic clothes carpets etc may cause damaging static discharges in a dry environ ment Do not use this meter near cellular or cordless telephones walkie talkies garage door openers radio transmitters or other electrical ...

Page 46: ...u see the flashing blood drop icon before you add blood or control solution sample The meter elec tronic or test strip is damaged Remove the battery and turn on the meter again Remove the test strip and insert a new test strip again If problem persists Please call your author ized dealer in your country with questions and concerns mg dL AM ctl mg dL AM ctl mg dL AM mg dL AM g dL AM AM AM mg dL mmg...

Page 47: ...ip If the result is still HI contact your physician or health care professional immediately Test result is lower than 20 mg dL Wash and dry your hands and repeat the test using a new test strip If the result is still LO contact your physician or health care professional immediately AM gl dL mmgl dL mmgl dL mg dL AM mg dL mg dL g dL DAY AVG mg dL DAY AVG AM AM AM mg dL AM AM g dL mmgl dL mmgl dL mm...

Page 48: ...Up Your New System on page 11 Start testing your blood glucose see Test ing Your Blood Glucose on page 28 Temperature out of range Move the meter into an area that is be tween 10 C 40 C 50 F 104 F and allow 10 to 15 minutes for it to reach the new temperature g dL AM ctl mg dL AM ctl mg dL AM mg dL AM AM g dL mmgl dL mmgl dL mmgl dL mg dL AM g dL DAY AVG mg dL DAY AVG mg dL DAY AVG mg dL AM AM gl ...

Page 49: ...Biotechnology Corporation be liable for any collateral or consequential damages or loss Instruments subjected to misuse abuse neglect unauthorized repair or modification will be excluded from this warranty This guarantee specifically excludes expendables and consumables All warranty claims must be directed to the Apex Biotechnology Corporation authorized dealer responsible for the sale of the syst...

Page 50: ...s averaging Dimension 76L x 45w x 15 5H mm Weight 29g Battery 1 x CR 2032 3V Lithium coin cell battery Battery Life 1000 tests of continuous use or one year Automatic Power off After1 5 minutes of nonuse Operating Temperature 10 C 40 C 50 F 104 F Relative Humidity Less than 85 Storage Condition Meter at 4 C 50 C 39 F 122 F Test Strips at 4 C 30 C 39 F 86 F Blood Glucose Monitoring System 50 GS Aut...

Page 51: ...omagnetic Compatibility This equipment complies with EMC requirement of EN 60601 1 2 EU directive classification 98 79 EC Annex II List B For additional information refer to the GlucoSure Plus Test Strip insert Blood Glucose Monitoring System 51 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 47 PM Page 51 ...

Page 52: ...tch code Temperature limitation Consult instructions for use In vitro diagnostic medice device Caution catalogue number Keep away from sunlight Do not re use Manufacturer Authorised Representative in the Europ Blood Glucose Monitoring System 52 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 47 PM Page 52 ...

Page 53: ...Sure Autocode 50 s Test Strip S5640090 GlucoSure Autocode 2x25 s Test Strip S5800091 CONTREX Plus Ⅲ Glucose Control Solution L1 L2 65235010002 Lancing Device 80050000003 Apex Lancet 50s 80050000004 Apex Lancet 250 s Blood Glucose Monitoring System 53 GS Autocode 1A manual CE 711 BK white 2011 10 12 1 47 PM Page 53 ...