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Dear GlucoSure STAR Owner

Thank you for choosing the GlucoSure STAR Blood Glucose Monitoring Sys-

tem to help you monitoring your blood sugar levels.

Your new GlucoSure STAR Blood Glucose Monitoring System is designed

with convenience and accuracy in mind to make your life a little easier. All of

the information needed to use and maintain your new meter is included in this

manual. Please read it carefully.

Your GlucoSure STAR 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 compari-

son to lab results. The GlucoSure STAR Blood Glucose Monitoring System is

a portable battery operated meter intended for use as an aid by persons with di-

abetes and by health care professionals to monitor glucose concentration in

whole blood.

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Summary of Contents for GlucoSure STAR

Page 1: ...ead it carefully Your GlucoSure STAR 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 T...

Page 2: ...een 7 The GlucoSure STAR Blood Glucose Test Strip 10 Setting Up Your New System EInserting or Changing the Battery 11 ECoding the Meter 13 ESetting the Clock 15 ETurning ON OFF Beep Sound 20 Control S...

Page 3: ...Blood Glucose Test 35 Understanding Your Blood Glucose Test Results 41 Viewing Stored Readings and 7 14 30 Days Average from Memory 43 Caring for the Meter Cleaning the Meter 47 Storage and Precaution...

Page 4: ...luded in some areas STAR 4 Understanding Your New Blood Glucose Kit MENU ENTER Blood Glucose Meter N s u s G A M u G 0800 050100 e mail info apexbio com w ww CONTREX PLUS A G1 Y t 2 Y t T N LOT G EXP...

Page 5: ...or Setup or exit and return to testing when viewing meter memory or setup Test Strip Port This is where you insert the test strip and the Meter will turn on automatically Scroll Buttons Press for scro...

Page 6: ...r New Blood Glucose Kit Battery Compartment Holds two 1 5V AAA batteries Code Card Port Insert the code chip see page 13 here Ejection Switch Push and eject a used test strip see page 10 Meter will be...

Page 7: ...Meter Display Screen STAR 7 Understanding Your New Blood Glucose Kit HAPPY SAD FACE BEEPER CODE TEMPERA TURE TEST STRIP MONTH DAY DAY AVG MINUTES HOUR MINUTES BLOOD DROP and ARROW UNITS MAIN DIS PLAY...

Page 8: ...or too cold to test outside the ranges of 10 C 40 C 50 F 104 F TEST STRIP This icon will flash to prompt you to insert a test strip for testing CTL This icon indicates a control solution test see pag...

Page 9: ...e display area is a stored test value see page 43 UNITS Unit of measurement for your blood glucose DISPLAY AREA Displays code number test results stored test val ues calculated result averages and mes...

Page 10: ...meaningful result IMPORTANT Be sure to use only the GlucoSure STAR Blood Glucose Test Strip with the GlucoSure STAR Blood Glucose Meter Other brands of test strips will not work with the Meter The Glu...

Page 11: ...d Two Alkaline AAA Batteries Supplied in Kit Your GlucoSure STAR Meter Step 1 Press firmly on the battery cover and slide in the direction of the arrow to open the cover Step 2 Insert new batteries ac...

Page 12: ...ither by a Test Strip or pressing If it is correct press again to exit or if the time and date are not correct see page 15 for Setting the Clock The date code number and stored results will not be era...

Page 13: ...Blood Glucose Test Strip Your GlucoSure STAR meter Step 1 Insert the code card with the connectors facing up Make sure it is completely Inserted into the code card port Step 2 Take out a GlucoSure ST...

Page 14: ...while the meter is turned on The display screen will flash and show the new code number from the code card Make sure the numbers from the meter display screen the code card and the test strip package...

Page 15: ...s of self tests will appear on the screen when all tests are complete If or other error messages Err 1 Err 2 etc appears see Solving Problems on page 49 Step 3 After the 4 digit code number and a flas...

Page 16: ...orrect year Press the button to confirm your choice and to advance to set the month Set month Step 5 The current month will flash Use the or buttons to select the correct month Press the to confirm yo...

Page 17: ...ay Press the button to confirm your choice and to advance to set the hour Set Hour Step 7 The current hour will flash Use the or buttons to select the correct hour Press the button to confirm your cho...

Page 18: ...r choice and ad vance into setting 12 hours or 24 hours time format Set Time Format to 12 hours or 24 hours Step 9 The current time format will flash Use or buttons to se lect either 12 hours format o...

Page 19: ...Test Strip and begin testing The changes you have done so far will be memorized by the meter Begin testing see page 30 Testing Your Blood Glucose or press and hold to turn off the meter or see the nex...

Page 20: ...rtant cues from your Meter such as confirmation or error messages Step 1 Press the button to confirm your choice and to advance to turning the beeper on or off Step 2 Use the Scroll Up or the Scroll D...

Page 21: ...ing The changes you have done so far will be memorized by the Meter Begin testing by inserting a GlucoSure STAR Blood Glucose Test Strip see page 30 Testing Your Blood Glucose or press to return to th...

Page 22: ...lus Level 1 Glucose Control Solution to check the system performance at low glucose concentrations You should perform control solution testing when Using the Meter for the first time You open a new bo...

Page 23: ...on three months after opening DO NOT FREEZE Store the control solutions at room temperature 15 C 30 C 59 F 86 F Materials you will need Contrex Plus Control Solution Level 1 or Level 2 Your GlucoSure...

Page 24: ...e opened on the test strip bottle label when you first open it 3 months after first opened date discard the bottle and any remaining Test Strip Make sure you are testing in an environment that is betw...

Page 25: ...should be the same IMPORTANT Always match the code number displayed on screen to the code number printed on the test strip bottle The code number on the test strip bottle and on the display must be t...

Page 26: ...icate that the Meter is in Control Solution Testing If you decide not to do a control solution test press twice to remove ctl from the meter display Step 4 Squeeze a drop of Contrex Plus Level 1 Contr...

Page 27: ...display count down bars that will gradually di minish After 6 seconds the control solution testing result will appear on the meter display screen Step 7 Compare the reading on the screen to the Level...

Page 28: ...o proper waste basket by either using the ejection button on the Meter or remove by hand The meter will automatically shut off after the Test Strip has been ejected or removed or will shut off after 2...

Page 29: ...the Meter Meter malfunction Control solution not at room temperature Make sure you are using Contrex Plus Con trol Solution Level 1 or Level 2 Make sure the testing environment is between 10 C to 40...

Page 30: ...st See Setting Up Your New System on page11 and Control Solution Testing on page 22 for de tails Wash your hands and testing site thoroughly with soap plus warm water and dry well You are testing in a...

Page 31: ...wn firmly until it is fully seated Step 2 Twist the protective cover off from the lancet Twist clockwise the adjustable cover back onto the lancing device Note For fingertip testing use the blue adjus...

Page 32: ...le cap pull back the lancing device with your other hand until you hear a click sound The lancing device is now ready for blood sampling IMPORTANT Use a new sterile lancet every time you test to avoid...

Page 33: ...s between your fingertip and palm and forearm 1 alternate site test result maybe significantly different then results from fingertip testing under certain conditions You should consult with your docto...

Page 34: ...testing do not agree with how you feel use finger tip testing instead 1 Jungheim K Koschinsky T Risky delay of hypoglycemia detection by glucose monitoring at the arm Diabetes Care 2001 24 7 1303 04...

Page 35: ...the test strip bottle and its package Do not use expired test strips Use each test strip immediately after removing it from the bottle Do not use wet or damaged test strips Keep away from direct sunl...

Page 36: ...reen IMPORTANT Replace the code card if code number displayed on screen and the code num ber printed on the test strip bottle do not match refer to Coding the Meter on page 13 Remember to change the c...

Page 37: ...button to create a puncture TIP Gently message 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 yo...

Page 38: ...t up For forearm test sites apply and release pressure Pumping for a few seconds while keeping the lancing device in constant contact with the skin Palm testing at the base of the thumb does not requi...

Page 39: ...bars that will gradually di minish After 6 seconds your glucose testing result will appear on the meter display screen Your test result will be automati cally stored into the meter memory CAUTION If y...

Page 40: ...tically shut off Step 7 Remove the used lancet from your lancing device according to instructions and discard into proper wastebasket IMPORTANT Discard used test strips and lancets according to your l...

Page 41: ...ter meal 1 It is important to consult with your physician or healthcare professional to de termine an appropriate target range for you What to do if you get a high or low reading If the Meter displays...

Page 42: ...bottle Repeat your test Test your Meter with a Control Solution refer to page 22 Control Solution Testing If you still get a high or low reading contact your health care professional Reference 1 Sted...

Page 43: ...track your effort in controlling your blood glucose level You will need to set your meter date and time to use the mem ory and day averaging function see Setting Up Your New System on page 15 The mete...

Page 44: ...isplay screen along with your most recent blood glucose testing or control testing result Press to see the next result Keep on pressing the to view older results one by one or hold it down to scroll t...

Page 45: ...rage is displayed you can press to go back viewing your averages and stored readings Note Control testing results will be flagged by a ctl icon on the bottom left corner of the display screen in addit...

Page 46: ...cause the oldest one to be deleted Memorized test results and day averages will not be erased when changing batteries After finish viewing memory or days averages either begin testing by inserting a G...

Page 47: ...a mild detergent Do not get water inside the GlucoSure STAR 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 tes...

Page 48: ...r removing a test strip and make sure it s 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 p...

Page 49: ...ired Check the test strip bottle and verify the expiration date Check the Code Number on both the Meter display screen and the test strip bottle or its package to make sure they match Check if Meter s...

Page 50: ...st Strip Not enough sam ple in the Test Strip to start Remove the Test Strip and repeat the test with a new Test Strip See Testing Your Blood Glucose on page 30 The Meter is damaged Remove the battery...

Page 51: ...r it to reach the new temperature Test result is higher than 600 mg dL 33 3 mmol L Wash and dry your hands and repeat the test using a new Test Strip If the result is still HI contact your physician o...

Page 52: ...ange the battery according to page 11 Inserting or changing the Battery There are no mem orized results in the Meter Check if the date and time on you Meter is set up See Setting Up Your New System on...

Page 53: ...and in no event shall Apex Biotechnology Corporation be liable for any collateral or consequential damages or loss Instruments subjected to misuse abuse neglect unauthorized repair or modifi cation wi...

Page 54: ...e Large LCD screen Memory 300 blood test results with date and time Result Averaging 7 14 and 30 days averaging Dimension 90L x 53W x 20H mm Weight 80g Battery 2 Alkaline AAA Battery Battery Life 1000...

Page 55: ...on according to IEC EN 60601 1 IPXO not evaluated as AP APG equipment continuous operation Electromagnetic Compatibility This equipment complies with EMC re quirement of EN 60601 1 2 EU directive clas...

Page 56: ...mperature limitations Consult instructions for use In vitro diagnostic device Caution warning consult accompanying documents Product code number Keep away from sunlight direct light Do not re use Manu...

Page 57: ...GlucoSure Star Kit mg dL S70008 GlucoSure Star Basic mmol L S70009 GlucoSure Star Kit mmol L S5636026 GlucoSure Star 25 s Test Strip mg dL S5636053 GlucoSure Star 50 s Test Strip mg dL S5636052 GlucoS...

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