Accu-Chek Advantage User Manual
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Accu-Chek Advantage User Manual

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BLOOD GLUCOSE METER
User's Manual
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  • Page 1 CCU- CCU- ® Advantage BLOOD GLUCOSE METER User’s Manual...
  • Page 3 Welcome Thank you for selecting the Accu-Chek Advantage System. Designed for ease of use, this system was produced in close association 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.
  • Page 4 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 included in this pack. Should you require further information, please study this User’s Manual.

  • Page 5: Table Of Contents

    Contents About the Accu-Chek Advantage Meter . . . vi Special Features ....viii About the Accu-Chek Advantage Plus Test Strip ......ix Inserting the Battery .
  • Page 6 Patient Testing for Healthcare Professionals ..... . . 28 Sample Handling ....28 Testing Blood Glucose in Multiple Patients .
  • Page 7 Softclix Finger Pricker....65 Accu-Chek Softclix Lancet ... . 65 Product Safety Information ... . 66 Disposing of the Meter .

  • Page 8: About The Accu-Chek Advantage Meter

    About the Accu-Chek Advantage Meter ON/OFF Button Press to turn meter ON or OFF. Serial Port Used to transfer data. Display Shows blood glucose result, messages, and glucose results stored in memory. Right and Left Buttons Used for meter setup and review of memory.
  • 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. Code Chip Slot Insert code chip here.

  • Page 10: Special Features

    Special Features The meter is designed to store information important to you and your healthcare professional. 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.

  • Page 11: About The Accu-Chek Advantage Plus Test Strip

    About the Accu-Chek Advantage Plus Test Strip Electrodes Insert test strip with silver-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.

  • Page 13: Inserting The Battery

    Inserting the Battery The meter is shipped with one 3-volt battery type 2032 that needs to be inserted before testing. The battery that comes with the meter can be found in the mesh pocket of the carrying case. Battery life varies depending on usage, so always keep a spare packaged battery on hand.

  • Page 14: Battery Symbol On The Display

    2. Insert the 3-volt battery (type 2032) into the compartment with “+” side 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.
  • Page 15 If a flashing battery symbol appears on the display, the battery is nearly dead. Battery must be replaced to continue testing. After changing the battery, the meter prompts you to verify the time and date immediately after the battery is inserted, if time and date had previously been set.

  • Page 16: Setting The Beeper, Time, Date, And Hypo Flag

    Setting the Beeper, Time, Date, and Hypo Flag Turning the Beeper On or Off Does the beeper have to be turned 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.
  • Page 17 3. Press and hold down the ON/OFF button until “set” appears at the bottom of 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.

  • Page 18: Setting The Time And Date

    5. Press and hold down the ON/OFF button until the test strip symbol flashes or code and “---” appear 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.
  • Page 19 5. Press and release the ON/OFF button. The hour display flashes. 6. Press and release the right or left arrow button until the correct hour is displayed. 7. Press and 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.

  • Page 20: Setting The Hypo Flag

    Setting the Hypo Flag The hypo flag allows you to define your hypoglycemic level and receive a reminder whenever you obtain a blood glucose result below this level. You can set the hypo indicator level to any number between 3,3 and 4,4 mmol/L.

  • Page 21: Coding Your Meter

    Each code chip provides the meter with the specific information that the meter needs to accurately measure blood glucose. Do not use code chips with your Accu-Chek Advantage Meter from any test strip manufacturer or system other than the Accu-Chek Advantage System from Roche Diagnostics.
  • Page 22 The code chip is properly inserted when it snaps into place. You need to insert a new 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.

  • Page 23: Testing

    Testing Gathering Supplies To 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 Glucose in Multiple Patients.”...
  • Page 24 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). 3. Remove a new test strip from the container.
  • Page 25 5. Let your arm hang down at your side briefly to allow blood to flow to your fingertips. 6. Grasp your finger just below the joint closest to the fingertip, and squeeze for three seconds. 7. Obtain a blood sample. Use the lancet to obtain a drop on the side of your finger.
  • Page 26 10. The blood glucose result is displayed in mmol/L. If your meter displays mg/dL contact the Accu-Chek Customer Careline on 0800 701 000 (UK) or 1 800 709 600 (Ireland). Using the wrong meter can cause you to wrongly interpret the test result.
  • Page 27 11. Remove the test strip from the meter. Discard the used test strip and lancet in a puncture- proof container with a lid. If you have completed your testing, turn the meter OFF, or the meter automatically turns off five seconds after removing the test strip.

  • Page 28: Marking A Result With A Flag, Asterisk ( )

    Marking a Result with a Flag, Asterisk ( ) This feature allows you to perform a test and mark the result with a flag (asterisk) to be stored in memory. Each result flagged with the asterisk has special meaning only to you.

  • Page 29: Normal Blood Glucose Values

    Normal Blood Glucose Values These test strips are calibrated to deliver whole blood results. The normal fasting blood glucose range for an adult without diabetes is 3.5-5.3 mmol/L. people with diabetes: Please consult your healthcare professional for the blood glucose range appropriate for you.

  • Page 30: Do's And Don'ts

    Then perform a quality control check with glucose control solutions and a new test strip. (See “Quality Control Checks.”) If the control result is within the acceptable range, review proper testing 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.

  • Page 31: Correct Test Strip Appearance

    Correct Test Strip Appearance Although only a small amount of blood is needed, it is very important that you put enough blood 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.

  • Page 32: Using The Memory

    The Accu-Chek Advantage Meter also calculates 7-, 14- and 30-day averages. You do not have to set the time and date for the meter to give you average calculations.
  • Page 33 chip is installed, the code number appears briefly, followed 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.

  • Page 34: Quality Control Checks

    Quality Control Checks What are quality control checks? They ensure that you are doing a test correctly and that your system is working properly. When should I check my meter? • If you leave the cap off the container of test strips.
  • Page 35 Important: Make sure you use the proper control solution for the test strips you have: Accu-Chek Advantage Plus Test Strips require Accu-Chek Advantage II Glucose Control Solutions.

  • Page 36: Performing A Quality Control Check

    Performing a Quality Control Check 1. Open the test strip container and 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...
  • Page 37 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 38 Note: Result must be marked with an L1 or L2 for the meter to verify if the control result is within range. If result has not been marked with an L1 or L2, refer to the test strip container label for the glucose control ranges.

  • Page 39: Understanding Control Results

    • Did you select the appropriate control result level (L1 or L2)? Repeat the glucose control test. If the result is still not acceptable, contact the Accu-Chek Customer Careline on 0800 701 000 (UK) or 1 800 709 600 (Ireland).

  • Page 40: Patient Testing For Healthcare Professionals

    Note: Consumers – please proceed to the “Caring for Your Meter” section. The following sections are for healthcare professionals only. Patient Testing for Healthcare Professionals Sample handling Always wear gloves and follow your facility’s infection control procedures when handling blood-contaminated items.

  • Page 41: Testing Blood Glucose In Multiple Patients

    For healthcare professionals we recommend the Accu-Chek Safe-T-Pro Plus disposable finger prickers. Patients and healthcare workers are potentially at risk of becoming infected when the same blood glucose meter is used to test blood glucose in several patients.

  • Page 42: Performing A Blood Glucose Test

    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. Any object coming into contact with human blood...
  • Page 43 4. Use a finger pricker with adjustable penetration depth settings. If using a Safe-T-Pro Plus finger pricker, select a penetration depth to suit the nature of the patient’s skin. Start with a shallow depth setting. 5. Select a puncture site along the side of a fingertip. 6.

  • Page 44: Flagging Test Results

    Flagging Test Results It is possible to flag a test result with an asterisk ( ) for a special result. When the results in memory are reviewed, this flag is a reminder of a special result. 1. Perform a test. 2.

  • Page 45: Normal Blood Glucose Values

    Dispose of used lancets, test strips or disposable finger prickers according to local health and safety regulations. Note: The test strip cannot properly draw up blood that has spread over the skin. Normal Blood Glucose Values These test strips are calibrated to deliver plasma-like results.

  • Page 46: Troubleshooting Checks

    Troubleshooting Checks 1. Check if the test strips were expired. 2. Check if the cap on the test strip container was always 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.

  • Page 47: Disinfecting The Meter

    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”). What to Disinfect...

  • Page 48: How To Disinfect

    How to Disinfect • Make sure the meter is off. • Gently wipe the meter’s surface. • Cotton buds, wipes and cloths lightly moistened with disinfectant are all suitable for disinfecting the meter. • Allow areas you have wiped time to dry thoroughly. •...

  • Page 49: Suitable Disinfecting Cleaning Solutions

    If blood has entered the meter, wipe the area around the test strip slot and the display screen. Allow areas you have wiped time to dry thoroughly. The meter, including the test strip slot and display screen, must be thoroughly cleaned and disinfected at least once a day after use.

  • Page 50: Control Testing For Healthcare Professionals

    Control Testing for Healthcare Professionals Introduction Testing control solutions with known glucose levels establishes that 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.

  • Page 51: About The Control Solutions

    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.
  • Page 52 3. Press and release the right arrow button once to select a L1 (Level 1) control or twice to select a L2 (Level 2) control. Note: Results marked as L1 or L2 do not appear in memory or averages. 4. Hold the control bottle horizontally with the tip pointed directly at the right edge of the test strip.
  • Page 53 If result has not been marked with an L1 or L2, refer to the test strip container label for the glucose control ranges. Example of an acceptable Level 1 control result. 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”...

  • Page 54: Caring For Your Meter

    Caring For Your Meter Display 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.

  • Page 55: Storage And Handling

    • Via specialized modems designed for remote transfer Consider the following when using accessory equipment: • DO NOT run a glucose test when the Accu-Chek Advantage Meter is connected to accessory equipment. For more information please contact your healthcare...

  • Page 56: Quick Reference Display Guide

    Quick Reference 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. Meter is ready to accept a test strip.
  • Page 57 Blood glucose result appears on display. Blood glucose result may be higher 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.

  • Page 58: Memory Displays

    Temperature is above or below the operating 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.
  • Page 59 If you are reviewing memory and a result appears 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

    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. (flashing battery symbol)

  • Page 61: Quality Control Check Displays

    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.
  • Page 62 Example of an acceptable control result. Glucose control result is not acceptable. Repeat test. Refer to Understanding Control Results (see page 27). Example of an unacceptable control result.

  • Page 63: Error Messages

    If you continue to see this error message before you apply blood to the test strip call the Accu-Chek Customer Careline on 0800 701 000 (UK) or 1 800 709 600 (Ireland).
  • Page 64 Your blood glucose may be extremely high or a meter or test strip error has occurred. If this confirms how you feel, contact your healthcare professional immediately. If it does not confirm how you feel, repeat the test and refer to the section in the manual titled Understanding Your Test Results.
  • Page 65 Meter has detected the loss of all results in memory. Turn meter OFF and turn it back ON again. You may 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.

  • Page 66: Technical Data

    Technical Data Please read information packaged with test strips regarding up to date product specifications and limitations. Measuring Principle: The glucose dehydrogenase 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).

  • Page 67: Product Specifications

    Product Specifications Blood Volume 4μL Sample Type Fresh capillary whole blood Measuring 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.

  • Page 68: Electromagnetic Compatibility

    Interference from other electrically driven equipment is not to be anticipated. Performance Analysis The performance data for the Accu-Chek Advantage System (Accu-Chek Advantage Meter with Accu-Chek Advantage Plus Test Strips) were obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability) and control solution (reproducibility).

  • Page 69: Note On Patient Situation

    The Accu-Chek Advantage System complies with the requirements of EN ISO 15197. References 1. Stedman, 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.

  • Page 71: About The Accu-Chek Softclix Finger Pricker

    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 G Semi-circular cutout H Ejector I Transparent release button J Priming button...

  • Page 72: Accu-Chek Softclix Finger Pricker

    Accu-Chek Softclix Finger Pricker Introduction The Accu-Chek Softclix finger pricker is an easy-to-use finger pricking device for obtaining blood from the tip of the finger or the earlobe virtually without pain. Penetration depth can be adjusted precisely to suit individual skin requirements.
  • Page 73 For this purpose the Accu-Chek Softclix finger pricker can be set to different penetration depths ranging from 0.5 to 5.5. They are indicated on the cap by the numbers 1 to 5. The additional intermediate settings marked with dots enable a particularly precise adjustment of Accu-Chek Softclix finger pricker to suit individual skin type.

  • Page 75: How To Take A Blood Sample

    How to Take a Blood Sample 1. Pull off the cap from the Accu-Chek Softclix finger pricker. 2. Insert a new Accu-Chek Softclix lancet as far as it goes into the lancet holder and push it in until it clicks.

  • Page 76: Selecting The Puncture Site

    Then carry out the test according to the instructions 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.

  • Page 77: Subsequent Treatment Of The Puncture Site

    (follow the manufacturer’s instructions). Accu-Chek Softclix Lancet Use the Accu-Chek Softclix lancet to operate the Accu-Chek Softclix finger pricker. These lancets are manufactured to such a high standard of accuracy that the individual penetration depth selected on...

  • Page 78: Product Safety Information

    Directive 2002/96/EC—Directive on waste electrical and electronic equipment (WEEE). Explanation of Symbols Accu-Chek Advantage Meter On packaging, on the type plate and in the parts of this manual dealing with the meter you may encounter the following symbols, shown here with...
  • Page 79 Please consult instructions for use Caution (refer 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 Catalogue number Lot number...
  • Page 80 3-volt lithium battery (coin cell 2032) Accu-Chek Softclix Finger 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...

  • Page 81: Warranty And Service Instructions

    Supplies and Accessories The following supplies and accessories are available from pharmacies or your local surgical supplier: Accu-Chek Advantage Plus Test Strips Accu-Chek Advantage II Glucose Control Solutions Accu-Chek Softclix Lancets Accu-Chek Softclix Finger Pricker...
  • Page 82 Accu-Chek Softclix Finger Pricker Guarantee The Accu-Chek Softclix Finger Pricker is guaranteed for life from the date of purchase against defects in materials or workmanship. 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.

  • Page 83: Index

    Index About the Accu-Chek Softclix Finger Pricker ..59 About the Accu-Chek 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 ............
  • Page 84 Error messages ............51 Flag (asterisk) ............16 Gathering supplies for testing ......... 11 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 ............
  • Page 85 Testing, 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 ..............

  • Page 86: Any Questions

    1 800 709 600 (Ireland) *Calls may be recorded for training purposes The Accu-Chek Advantage System, including the meter, code key, and test strips, is covered by the following patents: European Patent Nos. 0 460 074, 0 505 494, 0 705 348, and 0 406 304; and British Patent Nos.
  • Page 89 This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
  • Page 90 ACCU-CHEK, ADVANTAGE, and SOFTCLIX are trademarks of Roche. Accu-Chek Customer Careline* 0800 701 000 (UK) 1 800 709 600 (Ireland) *Calls may be recorded for training purposes Distributed by: Roche Diagnostics Limited Charles Avenue Burgess Hill West Sussex RH15 9RY...

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