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  5. Reference Manual

Accu-Chek 98/79/EC Reference Manual

Manual is about: Accu-Chek Reference Guide Blood Glucose Monitor 98/79/EC

Summary of 98/79/EC

  • Page 2

    This product fulfills the requirements of directive 98/79/ec on in vitro diagnostic medical devices..

  • Page 3: Welcome

    Welcome thank you for selecting the accu-chek ® sensor system. Designed for ease of use, this system was produced in close association with diabetes health- care professionals, hospitals and, most importantly, people with diabetes. The accu-chek sensor system is intended for self-testing of glucose ...

  • Page 4

    Ii.

  • Page 5: Contents

    Contents about the accu-chek sensor meter . . . . . .V special features . . . . . . . . . . . . . . . . . . . .Vii about the accu-chek sensor comfort test strip . . . . . . . . . . . . . . . . . . . . . . . . .Viii inserting the battery . . . . . . . . . . . . . . . . . .1 battery symbol on the disp...

  • Page 6

    Caring for your meter . . . . . . . . . . . . . . . .28 display check . . . . . . . . . . . . . . . . . . . . .28 cleaning . . . . . . . . . . . . . . . . . . . . . . . . .28 storage and handling . . . . . . . . . . . . . . .29 note to healthcare professionals . . . . . . .30 transferring data . . ....

  • Page 7: About The Accu-Chek

    V about the accu-chek ® sensor 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 strip...

  • Page 8: Code Key

    Vi about the accu-chek sensor meter 446 731 code key for coding/ calibrating your meter. New code key comes with every vial of test strips. Battery cover remove cover to change battery. Code key slot insert code key here..

  • Page 9: Special Features

    Special features your meter is designed to store information important to you and your healthcare professional. The memory will store 480 readings. Along with these readings, the meter can store additional important information. The hypo flag allows you to define your hypoglycemic level and receive ...

  • Page 10: Viii

    Viii about the accu-chek ® sensor comfort test strip electrodes insert 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 – this window should be completely yellow. After applying blood – this window should be...

  • Page 11: Inserting The Battery

    Inserting the battery your meter is shipped with one 3-volt battery type 2032 (cr 2032, dl 2032, or equivalent) that needs to be inserted before testing. The battery that comes with your meter can be found in the mesh pocket of your carrying case. Battery life will vary depending on usage, so always...

  • Page 12: Battery Is Low.

    2. Insert the 3-volt battery (type 2032) into the compartment with “+” side facing you. 3. Snap battery cover back in place. If time and date feature was set previously, the meter will turn on automatically. Confirm that the time and date are set correctly. If time and date have not been set previou...

  • Page 13: Battery Must Be Replaced

    If a flashing battery symbol appears on the display, the battery is nearly dead. After changing the battery, your meter will prompt 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, date and year on page 6. Note...

  • Page 14: And Hypo Flag

    Setting the beeper, time, date, year, 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 will still sound. The meter...

  • Page 15

    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 16

    5. Press and hold down the on/off button until strip icon is seen flashing or code and “---” appear to leave this function. Setting the time, date and year 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 pla...

  • Page 17

    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 18: 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 sugar result below this level. You can set the hypo indicator level to any number between 60 and 80 mg/dl (3,3 and 4,4 mmol/l). Important note: consult with your health...

  • Page 19: Called Coding/calibrating.

    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 strip symbol or code and “---” are displayed. Coding/calibrating your meter what is coding/calibrating, and when is it necessary? B...

  • Page 20

    A code key is properly inserted when it snaps into place. You will need to insert a new code key: • whenever you open a new box of strips. • whenever either one of these displays appear: 1. Make sure meter is turned off. Turn meter over so you are looking at the back. Remove old code key if one is i...

  • Page 21: Testing

    Testing gathering supplies to begin testing, you will need the following items: • accu-chek ® sensor meter • accu-chek ® sensor comfort test strips • accu-chek ® softclix lancet • accu-chek ® softclix lancing device performing a test 1. Wash your hands in warm, soapy water. Rinse well and dry comple...

  • Page 22: From Vial. Be Sure to

    3. Remove new test strip from vial. Be sure to tightly replace vial cap after removing test strip. 4. Within 3 minutes, insert test strip into test strip slot with silver-coloured bars facing up and toward the meter. The meter turns on automatically. Check that the code number on the meter matches t...

  • Page 23: 8. Touch and Hold Drop of

    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 3 seconds. 7. Obtain blood sample. Use the lancet to obtain a drop on the side of your finger. Do not obtain the drop from the...

  • Page 24

    9. When blood is applied to strip, an hourglass flashes on the display until measurement is completed. Result appears. 10. The blood glucose result is displayed in mg/dl or mmol/l. Your result is automatically recorded in the meter’s memory. You may also want to record the glucose value in your reco...

  • Page 25: The Section Understanding

    11. Remove test strip from meter. Discard the strip and lancet in a puncture-proof container with a lid. If you have completed your testing, turn the meter off, or the meter will automatically turn off 5 seconds after removing the strip. If hi is displayed, your blood glucose result may be higher th...

  • Page 26

    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 will have special meaning only to you. For your healthcare professional, you should record the meaning along w...

  • Page 27

    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 following: • does the test strip number on the vial match the code number on the meter? • was the bloo...

  • Page 28: Do’S and Don’Ts

    Do’s and don’ts do: • tightly replace vial lid immediately after removing a test strip. • make sure code number on meter matches code number on strip vial label. • keep meter clean. • store strips in the original vial. Don’t: • store strips outside original vial. • use expired test strips. • use cod...

  • Page 29: Proper Test Strip Appearance

    Proper test strip appearance although only a small amount of blood is needed, it is very important that you put enough blood on your test strip so that the entire yellow window is filled with blood. This ensures that your meter can produce accurate and reliable results. Very small amounts of blood m...

  • Page 30: Using Memory

    Using 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 accordin...

  • Page 31

    Followed by the most recent result stored in memory. If no code key 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, or press the righ...

  • Page 32: 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 vial of test strips. • before using your meter for the first time. • when you open a new vial...

  • Page 33: Comes First.

    To do a quality control check, you need: • accu-chek ® sensor comfort glucose control solutions (level 1 and level 2) • accu-chek ® sensor comfort 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 goo...

  • Page 34: In Memory Or Averages.

    Performing a quality control check 1. Open test strip vial and remove test strip. Replace vial cap. 2. Within 3 minutes, insert 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 vial of test st...

  • Page 35

    5. Gently squeeze the bottle to form one small drop. 6. Bring the drop to the edge of the strip within the curve, and allow the strip to automatically draw the solution into the yellow window until it is completely filled. An hourglass flashes in the display until the measurement is complete. 7. Tig...

  • Page 36

    Note: result must be marked with an l1 or l2 for the meter to verify if control result is within range. If result has not been marked with an l1 or l2, refer to your test strip vial label for the glucose control ranges. If result is not within the acceptable range, an icon of the control vial appear...

  • Page 37

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

  • Page 38: 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. Cleaning clean the outside of the meter, ...

  • Page 39: Storage and Handling

    Storage and handling keep your meter free of dust. Protect it from extremes in temperature and humidity, and handle it with care. If 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 store a ...

  • Page 40

    Note to healthcare professionals: follow the infection control procedures appropriate for your facility. A drop of fresh, whole blood is required to perform a blood glucose test. Fresh venous, capillary, arterial or neonatal blood may be used. Caution should be taken to clear arterial lines before b...

  • Page 41: Transferring Data

    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 in two different ways: • directly to your computer using a specialized software and interface cable • via specialized...

  • Page 42

    Quick reference display guide meter needs to be coded/ calibrated, or code key is not inserted completely; turn meter off and insert code key (see page 9). Meter is in the “set” function, allowing you to set the beeper, time, date, year, and hypo flag (see page 4). Meter is ready to accept a test st...

  • Page 43: Doctor’S Instructions.

    Blood glucose result appears on display (see page 14). Blood glucose result may be higher than 600 mg/dl (33,3 mmol/l). If this does not confirm the way you feel, review proper testing procedure and perform a quality control check (page 22). Repeat test. If hi still appears, follow your doctor’s ins...

  • Page 44: 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 5 minutes, and repeat the test. Do not artificially heat or cool the meter. Memory displays the meter is in the “memory” functi...

  • Page 45: 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 averages....

  • Page 46: Display Messages

    Display messages battery displays battery power is low. Change battery soon. (battery symbol not flashing) battery is dead. Change battery now. Meter will turn off after 3 seconds. (flashing battery symbol) 36 i i i i i ii ii ii i i i i i.

  • Page 47

    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. 37 i i i i i i i i i i and i i i i i i i i i i.

  • Page 48

    Example of an acceptable control result. Or glucose control result is not acceptable. Repeat test. Refer to understanding control results (see page 27). Example of an unacceptable control result. Or 38 and and and and.

  • Page 49: 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 key is faulty, or the code key was removed wh...

  • Page 50: Test Results (See Page 17).

    Your blood sugar may be extremely high or a meter or 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 (see page...

  • Page 51

    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 52: 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 gluconolac- tone. This reaction liberates an electron that reacts with a coenzyme ele...

  • Page 53: Product Specifications

    Product specifications meter storage -25° to 70°c conditions >53.3 kpa atmospheric pressure system operating refer to your test strip package conditions insert for more information measuring range refer to your test strip package insert for more information memory capacity 480 blood glucose results ...

  • Page 54

    Power supply one 3-volt lithium battery type 2032 (cr 2032, dl 2032 or equivalent) data port 3-wire rs-232c serial port multiplexed ttl uart test strip refer to your test strip package storage conditions insert for more information construction hand held protection class iii rated operation continuo...

  • Page 55: Product Safety Information

    Product safety information explanation of symbols caution refer to accompanying documents. 3v type 2032 listed by underwriter’s laboratories, inc. ® in accordance with ul 61010a-1 and can/csa c22.2 no. 1010-1. This product fulfills the requirements of directive 98/79 ec on in vitro diagnostic medica...

  • Page 56

    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 57: Supplies and Accessories

    Supplies and accessories the following supplies and accessories are available from pharmacies or your local surgical supplier. Accu-chek sensor comfort test strips accu-chek sensor comfort glucose control solutions accu-chek softclix lancets accu-chek softclix lancing device 47.

  • Page 58: Index

    Index about your accu-chek sensor meter .........................V accu-chek sensor comfort test strip ....................Viii, 11 batteries ..............................................................1, 2, 3 battery display .................................................... 2, 3, 36 battery li...

  • Page 59: ) ............. 16

    Error messages ..........................................................39 flag (asterisk) ........................................................... 16 gathering supplies for testing ................................. 11 getting a good sample .................................................11 glu...

  • Page 60

    Specifications, product............................................. 43 storage conditions ................................................ 29, 43 storage and handling .................................................. 29 supplies and accessories.............................................47 testin...

  • Page 61: Any Questions

    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 sensor meter, accu-chek co...

  • Page 63: 2003/06

    Accu-chek and softclix are trademarks of a member of the roche group. 03654117001-0703 2003/06 roche diagnostics gmbh sandhofer strasse 116 d-68305 mannheim, germany www.Roche.Com.