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  4. ADVANTAGE
  5. User Manual

Accu-Chek ADVANTAGE User Manual

Other manuals for ADVANTAGE: Owner's Booklet, Owner's Booklet, User Manual

Summary of ADVANTAGE

  • Page 1

    Blood glucose meter user’s manual a a ccu- ccu- c he hek ® advantage.

  • Page 3: Welcome

    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 glucos...

  • Page 4: Document M29-A3, 2005).

    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 is a potential source of infection (see: clinical and...

  • Page 5: Contents

    Contents about the accu-chek advantage meter . . . Vi special features . . . . . . . . . . . . . . . . . . . . Viii about the accu-chek advantage plus test strip . . . . . . . . . . . . . . . . . . . . . . . . . . . Ix inserting the battery . . . . . . . . . . . . . . . . . . 1 battery symbol on the...

  • Page 6: Professionals

    Patient testing for healthcare professionals . . . . . . . . . . . . . . . . . . . . . . . 28 sample handling . . . . . . . . . . . . . . . . . . . 28 testing blood glucose in multiple patients . 29 performing a blood glucose test . . . . . . . . 30 flagging test results . . . . . . . . . . . . . . ...

  • Page 7: Error Messages

    Error messages . . . . . . . . . . . . . . . . . . . . . 51 technical data . . . . . . . . . . . . . . . . . . . . . . 54 product specifications . . . . . . . . . . . . . . . 55 electromagnetic compatibility . . . . . . . . . 56 performance analysis . . . . . . . . . . . . . . . . 56 note on patient...

  • Page 8: Display

    Vi about the accu-chek advantage meter display shows blood glucose result, messages, and glucose results stored in memory. On/off button press to turn meter on or off. Right and left buttons used for meter setup and review of memory. Serial port used to transfer data. Test strip slot insert test str...

  • Page 9: Vii

    Vii 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 remin...

  • Page 11: Test Strip

    Ix 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. After applying blood – the window should be ...

  • 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 Is Low.

    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. If the time and date had not been set ...

  • Page 15: Note:

    If a flashing battery symbol appears on the display, the battery is nearly dead. 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. See “setting the time and date.” note: to retain the cor...

  • Page 16: 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. The meter is set to ...

  • 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. The se...

  • 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...

  • 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 ...

  • 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. Important note: consult with your healthcare professiona...

  • Page 21: Coding The Meter

    5. Press and release the right or left arrow button to turn on the hypo flag. 6. Briefly press and release the on/off button. “hypo” flashes, and the current hypo indicator setting, “set,” and “mmol/l” appear on the display. 7. Press and release the right or left arrow button to adjust the hypo flag...

  • 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. Remove the old cod...

  • 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 patient...

  • 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...

  • Page 25: Touch and Hold Drop

    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. Do not obtain the drop fr...

  • Page 26: Test Result.

    9. 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. If your meter displays mg/dl contact the accu-chek customer careline on 0800 701 000 (uk)...

  • 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. If hi is displayed, your blood glucose ...

  • Page 28

    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. For your healthcare professional, you should record the meaning along with yo...

  • 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. 1 for 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 sti...

  • Page 31

    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. Very small amounts of blood ma...

  • Page 32: Using The Memory

    Using the memory the meter automatically stores 480 glucose results, letting you review them in order from the most recent to the oldest. If you have set the time/date feature, the time and date of the results are also displayed. If time and date are not set, each result is marked with a number acco...

  • 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. Once in the memory mode: press the left arrow button to...

  • 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. • before using the meter for the first time. • when you open a new ...

  • Page 35: Comes First.

    To do a quality control check, you need: • accu-chek advantage ii glucose control 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 ...

  • Page 36: In Memory Or Averages.

    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...

  • 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. An hourglass symbol flashes in the display until the measurement is...

  • Page 38: Ranges.

    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. If result is not within the acceptable range, a control bottle symbol ap...

  • Page 39

    Understanding control results if your glucose control results are within the acceptable range, you can feel confident that the test strips and meter are working correctly. If one or both of your glucose control results are outside of the acceptable range, the system may not be working properly. Chec...

  • Page 40: Sample Handling

    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-contamina...

  • Page 41: Patient.

    Testing blood glucose in multiple patients only healthcare professionals are allowed to perform blood glucose tests in a multiple patient testing situation. When using the meter always follow the recognized procedures for handling objects that are potentially contaminated with human material. Practi...

  • Page 42: An Infection Risk.

    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 is a potential source of infection (see: clinical and...

  • 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. Insert a test strip into...

  • Page 44: Flagging Test Results

    32 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. With the test result on the display, and the test strip still in the meter, press the r...

  • Page 45: Normal Blood Glucose Values

    33 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. The n...

  • 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. 5. Check if the testing steps...

  • Page 47: Disinfecting The Meter

    4. Repeat the test with a properly stored test strip. 5. Read “patient testing for healthcare providers” and test again. If you still have problems, call roche. 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...

  • Page 48: How to Disinfect

    36 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. • remove any fluff or lint that may remain. • ref...

  • Page 49

    37 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. Carefully chec...

  • Page 50: Introduction

    38 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 inter...

  • Page 51: About The Control Solutions

    39 control results must be within the designated range on the test strip container label, or as defined by your facility, before being considered acceptable. Patients can be tested after controls have been acceptably performed at the proper testing interval. About the control solutions • only use ac...

  • Page 52: Memory Or Averages.

    40 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 st...

  • Page 53: Glucose Control Ranges.

    41 example of an acceptable level 1 control result. 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 unacceptable level 1 control result. 9. Remove the used test strip from meter and discard. If result is not within...

  • Page 54: Caring For Your Meter

    42 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. Cleaning clean the outside of the mete...

  • Page 55: Storage and Handling

    43 storage and handling keep the meter free of dust. Protect it from extremes in temperature and humidity, and handle it with care. If the meter is dropped, perform a quality control check with the glucose control solutions before doing a blood glucose test. The travel case is designed to let you st...

  • Page 56

    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. Blood drop can be applied to tes...

  • 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. Blood gl...

  • 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. Memory displays the meter is in the “memory”...

  • Page 59: To Make Therapy Adjustments.

    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 averag...

  • 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) 48.

  • 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 49.

  • 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. And and 50

  • Page 63: Error Messages

    Error messages the meter automatically performs a system check to prevent inaccurate results. If the meter detects 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 ...

  • Page 64: Mmol/l Error

    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. I...

  • 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. Move to an ar...

  • 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 elect...

  • Page 67: Product Specifications

    Product specifications blood volume 4 μ l 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 m...

  • Page 68: Performance Analysis

    Construction hand held protection class iii rated operation continuous operation data port 3-wire rs-232c serial port electromagnetic compatibility this meter meets the electromagnetic immunity requirements as per iso 15197 annex a. The chosen basis for electrostatic discharge immunity testing was b...

  • Page 69: References

    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 70

    A b d e f g h i j c 58.

  • Page 71: 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 59.

  • Page 72: Introduction

    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. The ac...

  • 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 ...

  • Page 74

    2 3 4 5 7 6 1 62.

  • 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. 3. To remove the protective cap, twist and then pull it. 4. Press the accu-chek softclix finge...

  • Page 76: Selecting The Puncture Site

    Wait a few seconds to allow the puncture site to open so that a drop of blood can form. Apply the blood drop to the test strip. 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. ...

  • Page 77: Softclix Finger Pricker

    Subsequent treatment of the puncture site wipe the puncture site with a dry, clean tissue. If it continues to bleed, apply gentle pressure to the puncture site with a plaster to protect it from dirt or infection. Cleaning and disinfecting the accu-chek softclix finger pricker to clean the accu-chek ...

  • Page 78: Product Safety Information

    Product safety information strong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter close to sources of strong electromagnetic radiation. To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthet...

  • 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...

  • Page 80

    Dispose of in domestic waste 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 for s...

  • Page 81: Statutory and Other Rights:

    Warranty and service instructions roche diagnostics warrants the meter against any material and manufacturing defects that may arise during proper use of the instrument. For precise terms and conditions please see the warranty card in the box. This warranty does not affect any statutory or other rig...

  • Page 82: Guarantee

    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...

  • 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 .........................................

  • Page 84: Error Messages

    72 error messages .......................................................... 51 flag (asterisk) ........................................................... 16 gathering supplies for testing ................................. 11 getting a good sample ................................................. 1...

  • Page 85: Testing, Blood Glucose

    73 testing, blood glucose ............................................. 11 testing, quality control ......................................... 22, 49 test strip slot ............................................................... Vi test strip container .............................................. ...

  • Page 86: Any Questions

    74 any questions we want to give you the help you need for long and reliable service of your meter. Review your test procedure and make sure that you are performing the steps correctly. If you still have questions, please contact roche diagnostics. Please have your accu-chek advantage meter, accu-ch...

  • Page 87

    75.

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    76.

  • 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 roche diagnostics gmbh, 68298 mannheim, germany www.Accu-chek.Com distributed by: roche diagnostics limited charles avenue ...