Accu-Chek ADVANTAGE User Manual Download

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BLOOD GLUCOSE METER

User’s Manual

CCU-

HEK

Advantage

Summary of Contents for ADVANTAGE

Page 1: ...BLOOD GLUCOSE METER User s Manual A ACCU CCU CHE HEK Advantage ...

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Page 3: ...on with diabetes healthcare professionals hospitals and most importantly people with diabetes The Accu Chek Advantage System is intended for self testing of glucose in capillary whole blood by people with diabetes Suitable for self testing Your new meter is designed for testing fresh capillary whole blood samples for example blood ...

Page 4: ...ect coming into contact with human blood is a potential source of infection see Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 Before using the Accu Chek Advantage Meter or Accu Chek Softclix Finger Pricker for the first time please refer to the Getting Started Guide inc...

Page 5: ...iii About the Accu Chek Advantage Plus Test Strip ix Inserting the Battery 1 Battery Symbol on the Display 2 Setting the Beeper Time Date and Hypo Flag 4 Turning the Beeper On or Off 4 Setting the Time and Date 6 Setting the Hypo Flag 8 Coding Your Meter 9 Testing 11 ...

Page 6: ... Performing a Blood Glucose Test 30 Flagging Test Results 32 Normal Blood Glucose Values 33 Unusual Test Results 33 Troubleshooting Checks 34 Action 34 Disinfecting the Meter 35 What to Disinfect 35 How to Disinfect 36 When to Disinfect 36 Suitable Disinfecting Cleaning Solutions 37 Control Testing for Healthcare ...

Page 7: ...ompatibility 56 Performance Analysis 56 Note on Patient Situation 57 Safety Remarks 57 About the Accu Chek Softclix Finger Pricker 59 Accu Chek Softclix Finger Pricker 60 Introduction 60 Selecting Depth of Penetration 60 How to Take a Blood Sample 63 Selecting the Puncture Site 64 ...

Page 8: ...About the Accu Chek Advantage Meter Display Shows blood glucose result messages and glucose results stored in ON OFF Button Press to turn meter ON or OFF Serial Port Used to transfer data ...

Page 9: ...About the Accu Chek Advantage Meter Code Chip For coding the meter A new code chip comes with every container of test strips Battery Cover Remove cover to change battery ...

Page 10: ...onal The memory stores 480 results Along with these results the meter can store additional important information The hypo flag allows you to define your hypoglycemic level and receive a reminder whenever you obtain a blood glucose result below this level See Setting the Hypo Flag for additional information ...

Page 11: ...lver coloured bars up and toward the meter Yellow Window Do not apply blood on the top of the test strip Before Applying Blood The window should be completely yellow After Applying Blood The window should be completely filled with the blood drop Note Any area of the test strip can be ...

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Page 13: ...f the carrying case Battery life varies depending on usage so always keep a spare packaged battery on hand The meter saves battery power by automatically turning off after 90 seconds of non use or five seconds after taking a test strip out of the meter following a test If the meter does automatically shut off all tests in memory are saved Note After changing the battery the meter prompts ...

Page 14: ...e facing you 3 Snap the battery cover back in place If the time and date feature was set previously the meter turns on automatically Confirm that the time and date are set correctly If the time and date had not been set previously wait five seconds then turn the meter ...

Page 15: ... the meter prompts you to verify the time and date immediately after the battery is inserted if time and date had previously been set See Setting the Time and Date Note To retain the correct time and date settings replace the battery before it is completely dead Battery must be replaced to continue testing ...

Page 16: ...urned on No it is an optional feature Turning the beeper on or off does not affect the test results If the beeper is turned off beeps that occur due to errors still sound The meter is set to beep when A test strip is inserted Blood or control solution is applied to the test strip A result is displayed ...

Page 17: ...f the screen Release the ON OFF button On set and the flashing beeper symbol appear on the display The beeper is now on Note You may leave the set mode at any time by pressing and holding the ON OFF button The settings you have entered are saved 4 Press and release the right ...

Page 18: ...r to leave this function Setting the Time and Date Do I have to set the time and date Time and date should be set prior to testing if you plan to download the results into software or if you plan to review the memory to check when a test was done To set the time and date 1 Press and release the ...

Page 19: ...nd release the ON OFF button The minute display flashes 8 Press and release the right or left arrow button until the correct minute is displayed 9 Press and release the ON OFF button The month display flashes 10 Press and release the right or left arrow button until the correct month is displayed 11 Press and release the ON OFF button The day display flashes ...

Page 20: ... the hypo indicator level to any number between 3 3 and 4 4 mmol L Important Note Consult with your healthcare professional to set the hypo marker to compliment your therapy Do not use the hypo marker as the only indicator of hypoglycemia Rely upon your symptoms and directions from your healthcare professional This function is no substitute for hypoglycemia training by your ...

Page 21: ...r setting set and mmol L appear on the display 7 Press and release the right or left arrow button to adjust the hypo flag setting 8 To leave this function press and hold down the ON OFF button until the flashing test strip symbol or code and are displayed Coding the Meter What is coding and when is it necessary Before you use the meter for the first time and every ...

Page 22: ...w code chip Whenever you open a new box of test strips Whenever either one of these displays appears 1 Make sure the meter is turned off Turn the meter over so you are looking at the back Remove the old code chip if one is installed 2 Insert the new code chip until it snaps into place ...

Page 23: ...begin testing you need the following items Accu Chek Advantage Meter Accu Chek Advantage Plus Test Strips Accu Chek Softclix Lancet Accu Chek Softclix Finger Pricker Performing a Test Healthcare professions please see Testing Blood ...

Page 24: ... Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 3 Remove a new test strip from the container Be sure to tightly replace the container cap after removing the test strip 4 Within three minutes insert a test strip into the test strip slot with silver ...

Page 25: ...he fingertip and squeeze for three seconds 7 Obtain a blood sample Use the lancet to obtain a drop on the side of your finger Do not obtain the drop from the pad of your finger To perform the test obtain a small drop of blood resting on your finger 8 Touch and hold drop of blood to the edge of the test strip within the curve Do not place the ...

Page 26: ... When blood is applied to the test strip an hourglass symbol flashes on the display until the measurement is completed The result appears on the display 10 The blood glucose result is displayed in mmol L ...

Page 27: ... have completed your testing turn the meter OFF or the meter automatically turns off five seconds after removing the test strip If HI is displayed your blood glucose result may be higher than 33 3 mmol L Refer to Understanding Your Test Results If LO is displayed your blood glucose result may be lower than 0 6 mmol L Refer to ...

Page 28: ...lt flagged with the asterisk has special meaning only to you For your healthcare professional you should record the meaning along with your reading in your Record Book or Diary An example includes using the asterisk to mark a result taken immediately after a meal To mark a result with a flag asterisk 1 Perform a blood glucose test and obtain the result ...

Page 29: ...ith diabetes Please consult your healthcare professional for the blood glucose range appropriate for you You should treat your low or high blood glucose as recommended by your healthcare professional Understanding Your Test Results If your blood glucose result seems unusually high low or inconsistent with your previous results or glucose trends and does not reflect the way you feel check the ...

Page 30: ...procedure and repeat your blood glucose test with a new test strip If your blood glucose value is still inconsistent with your previous results glucose trends or how you feel please contact your healthcare professional Follow the advice of your healthcare professional before you change your therapy Do s and Don ts DO TIGHTLY REPLACE THE CONTAINER LID IMMEDIATELY AFTER REMOVING A TEST STRIP ...

Page 31: ... on the test strip so that the entire yellow window is filled with blood This ensures that the meter can produce accurate and reliable results Notice that the left side of the yellow window is not completely filled with blood This test strip has too little blood and may produce This test strip has the correct amount of blood ...

Page 32: ...ed with a number according to how it falls in sequence If the memory is full and a new result is added the meter deletes the oldest result Results stored in memory are not lost when you replace the battery However to retain the correct time and date settings you must replace the battery before it is completely dead The Accu Chek Advantage Meter also calculates 7 14 and 30 day averages You do not h...

Page 33: ...by the most recent result stored in memory If no code chip is installed code and appear Press and release the right or left arrow button again to enter memory recall mode 2 Once in the memory mode Press the left arrow button to view individual results in memory ...

Page 34: ...system is working properly When should I check my meter If you leave the cap off the container of test strips Before using the meter for the first time When you open a new container of test strips If you drop the meter Whenever your result does not agree with the way you feel If you have repeated a test and the blood ...

Page 35: ...ol Solutions Level 1 and Level 2 Accu Chek Advantage Plus Test Strips Note When you open a new bottle of glucose control solution write the date on the label Opened bottles of glucose control solution are good for three months or until the expiration date whichever comes first ...

Page 36: ...nd remove a test strip Replace the container cap 2 Within three minutes insert the test strip yellow window facing up into test strip slot The meter turns on automatically Check that the code number on the meter matches the code on the container of test strips you Code ...

Page 37: ...to the yellow window until it is completely filled An hourglass symbol flashes in the display until the measurement is complete 7 Tightly replace the cap on control solution 8 The control result appears If result is within the acceptable range which is found on the side of the container of test strips a control bottle symbol appears on the screen while the control test result ...

Page 38: ...ith an L1 or L2 refer to the test strip container label for the glucose control ranges If result is not within the acceptable range a control bottle symbol appears on the screen while the control test result and time and date if set alternate with Err and L1 or L2 on the display See Understanding Control Results for more information and ...

Page 39: ...e or both of your glucose control results are outside of the acceptable range the system may not be working properly Check the following Did you use control solutions or test strips that were past their expiration date Did you leave the cap off the container of test strips or glucose control solutions Did the code in the meter match the code on the test strip container label ...

Page 40: ...are Professionals Sample handling Always wear gloves and follow your facility s infection control procedures when handling blood contaminated items Always adhere to the recognized procedures for handling objects that are potentially contaminated with human material Follow the health and safety policy of your laboratory or institution Prepare the selected ...

Page 41: ...When using the meter always follow the recognized procedures for handling objects that are potentially contaminated with human material Practise the health and safety policy of your laboratory or institution Also to stop your meter becoming contaminated please follow the directions printed on the next few pages For healthcare professionals we recommend the ...

Page 42: ...risk Any object coming into contact with human blood is a potential source of infection see Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 For healthcare professionals we recommend the Accu Chek Safe T Pro Plus or Accu Chek Safe T Pro Uno disposable finger prickers ...

Page 43: ...etting 5 Select a puncture site along the side of a fingertip 6 Insert a test strip into the meter 7 Make sure the code number on the meter display matches the code number on the test strip container 8 Lance the side of the fingertip 9 Using gentle pressure massage the finger towards the fingertip to encourage a drop of blood to form A proper but nevertheless small drop of blood approx 4 0 μL must...

Page 44: ...cial result 1 Perform a test 2 With the test result on the display and the test strip STILL IN THE METER press the right or left arrow button once The appears in the lower right corner 3 Remove and discard the used test strip and blood collection device per facility infection control policy To test blood glucose you require approximately 4 0 μL of blood Avoid producing ...

Page 45: ... spread over the skin Normal Blood Glucose Values These test strips are calibrated to deliver plasma like results The normal fasting blood glucose range for an adult without diabetes as related to plasma is 4 1 5 9 mmol L 1 Blood glucose concentrations may be measured in whole blood or in plasma Although whole blood is applied to the test strip the meter shows results that ...

Page 46: ...ys closed tightly 3 Check if the test strip was out of the container for a long time 4 Check if the test strips were stored in a cool dry place 5 Check if the testing steps were followed 6 Check if the code number on the meter display matches the code number on the test strip container 7 If the problem does not resolve ...

Page 47: ...che 6 If they do not match insert the correct code chip into the meter and test again 7 Repeat the test with a new test strip and perform a control test If the problem does not resolve call Roche Disinfecting the Meter The Accu Chek Advantage meter may be disinfected Disinfection is performed according to the degree of soiling see When to Disinfect ...

Page 48: ... and cloths lightly moistened with disinfectant are all suitable for disinfecting the meter Allow areas you have wiped time to dry thoroughly Remove any fluff or lint that may remain Refer to the section Cleaning the Meter for further information Notes Make sure that no liquid enters the meter ...

Page 49: ...eter including the test strip slot and display screen must be thoroughly cleaned and disinfected at least once a day after use Carefully check all recesses grooves and gaps Suitable Disinfecting Cleaning Solutions Products suitable for use are 70 Isopropyl Alcohol Mild washing up liquid mixed with water 10 household bleach solution 1 part bleach plus ...

Page 50: ... the operator and the system are performing acceptably Control results must be within the defined acceptable ranges before valid patient testing is allowed Testing Intervals Follow your facility s policy for control testing intervals Control testing should be performed The first time before using the meter for patient testing ...

Page 51: ...trols have been acceptably performed at the proper testing interval About the Control Solutions Only use Accu Chek Advantage Control Solutions Write the date the bottle was opened on the bottle label The control solution is stable for three months from that date or until the expiry date on the bottle label whichever comes first Do not use control solution that is past the expiry date ...

Page 52: ...ppear in memory or averages 4 Hold the control bottle horizontally with the tip pointed directly at the right edge of the test strip 5 Gently squeeze the bottle to form one small drop 6 Bring the drop to the edge of the test strip within the curve and allow the test strip to automatically draw the solution into the yellow window until it is completely filled ...

Page 53: ... an L1 or L2 refer to the test strip container label for the glucose control ranges If result is not within the acceptable range a control bottle symbol appears on the screen while the control test result and time and date if set alternate with Err and L1 or L2 on the display See and ...

Page 54: ...Check This verifies that all parts of the display are working Make sure the meter is off Press and hold down the ON OFF button The display should look exactly like the picture at right If it does not call Roche Diagnostics Cleaning ...

Page 55: ...trol check with the glucose control solutions before doing a blood glucose test The travel case is designed to let you store a variety of supplies you may need and helps to protect the meter Transferring Data The meter allows you to transfer all the data that you have stored in its memory to your computer so this information can be printed It allows you to transfer data ...

Page 56: ...ference Display Guide Meter needs to be coded or code chip is not inserted completely turn meter OFF and insert code chip Meter is in the set function allowing you to set the beeper time date year and hypo flag ...

Page 57: ...than 33 3 mmol L If this does not confirm the way you feel review proper testing procedure and perform a quality control check Repeat test If HI still appears follow your healthcare professional s instructions Blood glucose result may be lower than 0 6 mmol L If this does not ...

Page 58: ...ng range of test strips 14 to 40 C The result you have obtained may not be accurate Move to an area between 14 and 40 C wait five minutes and repeat the test Do not artificially heat or cool the meter Memory Displays The meter is in the memory ...

Page 59: ...pears with a temperature symbol as shown this result may not be accurate because the test was performed outside the operating range of the test strips 14 to 40 C The meter is in the memory function allowing you to recall 7 14 and 30 day averages ...

Page 60: ...Display Messages Battery Displays Battery power is low Change battery soon battery symbol not flashing Battery is dead Change battery now Meter turns off after three seconds ...

Page 61: ...Quality Control Check Displays Meter is ready for a Level 1 or Level 2 glucose control check Apply a drop of Level 1 or Level 2 glucose control solution and ...

Page 62: ...Example of an acceptable control result Glucose control result is not acceptable Repeat test Refer to Understanding Control Results see page 27 and and ...

Page 63: ...etects a malfunction it displays the Err message and an appropriate symbol Do not make treatment decisions based on an error message The code chip is faulty or the code chip was removed while the meter was on Turn meter OFF and re insert code chip If this error display still appears contact Roche Diagnostics ...

Page 64: ...rm how you feel repeat the test and refer to the section in the manual titled Understanding Your Test Results If this does not confirm the way you feel perform a quality control check with your glucose control solutions and a new test strip If the control result is within the acceptable range review the proper testing procedure and repeat your blood glucose test with a new test strip ...

Page 65: ... not be able to recall the results previously stored in memory although your meter will store any future test results Temperature is above or below the operating range of the meter Move to an area between 14 and 40 C wait five minutes and perform a test Do not artificially heat or I I I I I I I I I I I ...

Page 66: ...ase converts the glucose in a blood sample to gluconolactone This reaction liberates an electron that reacts with a coenzyme electron acceptor the oxidized form of the mediator hexacyanoferrate III forming the reduced form of the mediator hexacyanoferrate II The test strip employs the electromechanical principle of biamperometry The monitor applies a voltage between ...

Page 67: ...Range System measuring range is 0 6 33 3 mmol L Test Strip Storage Store test strips at room Conditions temperature between 2 to 32 C Do not freeze Accuracy Refer to your Test Strip Package Insert for more information Repeatability Refer to your Test Strip Package Insert for more information ...

Page 68: ...ts the electromagnetic immunity requirements as per ISO 15197 Annex A The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000 4 2 In addition it meets the electromagnetic emissions requirements as per EN 61326 Its electromagnetic emission is thus low Interference from other electrically driven equipment is not to be anticipated ...

Page 69: ...TL Stedman s Medical Dictionary 27th Edition 1999 p 2082 Note on Patent Situation The Accu Chek Softclix Finger Pricker is covered by European Patent Nos 1 034 740 0 565 970 and 0 782 838 Safety Remarks Only use an Accu Chek Softclix Lancet with the Accu Chek Softclix Finger Pricker since the use of ...

Page 70: ...A B D E F G C ...

Page 71: ...About the Accu Chek Softclix Finger Pricker A Cap B Depth selection arrow C Notch D Protective cap E Accu Chek Softclix lancet F Lancet holder ...

Page 72: ...od from the tip of the finger or the earlobe virtually without pain Penetration depth can be adjusted precisely to suit individual skin requirements The Accu Chek Softclix finger pricker is intended for patient self monitoring by a single person only It must not be used to collect blood from more than one person as this poses an infection risk ...

Page 73: ...arked with dots enable a particularly precise adjustment of Accu Chek Softclix finger pricker to suit individual skin type The markings on the device show the depth of penetration selected Penetration depth can be altered by turning the front part of the cap You will hear the cap click into position indicating adjustment to a new depth and simultaneously preventing any accidental alteration of pen...

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Page 75: ...ek Softclix lancet as far as it goes into the lancet holder and push it in until it clicks 3 To remove the protective cap twist and then pull it 4 Press the Accu Chek Softclix finger pricker cap on again until it clicks Be sure to align the notch on the cap with centre of the semicircular cut out on the ejector ...

Page 76: ...ions that come with the test strips or meter 7 To remove the lancet pull off the Accu Chek Softclix finger pricker cap To eject the used lancet slide the ejector forward to remove it and dispose of the lancet in a sealed container To avoid infections use a new lancet each time you take a blood sample Using each lancet only once helps ensure virtually pain free blood sampling ...

Page 77: ...it from dirt or infection Cleaning and Disinfecting the Accu Chek Softclix Finger Pricker To clean the Accu Chek Softclix finger pricker use any mild liquid detergent and a soft cloth Avoid immersing the device completely in liquid In addition disinfect the cap thoroughly about once a week by placing it for 10 minutes in a 70 alcohol solution available at your chemist or use another ...

Page 78: ... sources of strong electromagnetic radiation To avoid electrostatic discharge do not use the meter in a very dry environment especially one in which synthetic materials are present Disposing of the Meter During blood glucose measurement the meter itself may come into contact with blood Used meters therefore carry a risk of infection Please ...

Page 79: ...fer to accompanying documents Please refer to safety related notes in the manual accompanying this instrument Store at Use by Expiry date unopened opened Discard three months after opening or by the expiry date whichever comes first Manufactured by ...

Page 80: ...er Pricker On the finger pricker itself and on the packaging of Accu Chek Softclix Lancet you will encounter the following symbols shown here with their meaning Please read this note with special care For single use only The lancets may only be used up to the expiry date specified on the box ...

Page 81: ...e terms and conditions please see the Warranty Card in the box This warranty does not affect any statutory or other rights The warranty ceases to apply if the instrument has been misused or tampered with Roche undertakes to repair faulty components free of charge or at their discretion to provide a fault free replacement meter Be sure to fill out the warranty form that came with ...

Page 82: ...anship Please fill in the enclosed Warranty Card and return it to Roche Diagnostics Limited Our liability is explicitly limited to the elimination of demonstrable manufacturing defects This guarantee is rendered invalid if the instrument has been improperly operated or otherwise tampered with The guarantee period is not affected by any claim made under this guarantee ...

Page 83: ...k Advantage Meter vi Accu Chek Advantage Plus Test Strip ix 11 Accu Chek Softclix Finger Pricker Introduction 60 Battery 1 2 3 Battery display 2 3 Battery life 1 Battery cover vii 1 Battery installation 1 Beeper turning on or off 4 Blood sample 11 Caring for your meter 42 ...

Page 84: ...1 Getting a good sample 11 Glucose control solutions 23 HI display 15 31 How to take a blood sample 49 Hypo flag 8 Inserting test strip 12 Level 1 glucose control solution 22 Level 2 glucose control solution 22 LO display 15 31 Marking a result with a flag asterisk 16 ...

Page 85: ...blood glucose 11 Testing quality control 22 49 Test strip slot vi Test strip container 10 12 Time and date setting 6 Transferring data 43 Troubleshooting 17 22 27 51 Understanding control results 27 Warranty 69 ...

Page 86: ...ons please contact Roche Diagnostics Please have your Accu Chek Advantage Meter Accu Chek Advantage Plus Test Strips and Accu Chek Advantage II Glucose Control Solutions available when you call IMPORTANT READ CAREFULLY BEFORE USE GUARANTEE The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail Roche Diagnostics Limited Charles Avenue Burges...

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Page 89: ...This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices ...

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