ACCU-CHEK ® Integra BLOOD GLUCOSE MONITORING SYSTEM 0088 ACCU-CHEK, ACCU-CHEK INTEGRA and SOFTCLIX are trademarks of Roche. Complete Instructions for Use Roche Diagnostics GmbH D-68298 Mannheim, Germany www.accu-chek.com 0 4524381001(03) 2007-05 Roche Diagnostics Australia Pty Ltd. 31 Victoria Avenue Castle Hill, NSW 2154 Accu-Chek Enquiry Line: 1800 251 816 www.accu-chek.
On packaging, on the type plate of the meter, on the lancing device itself and in these instructions for use you may encounter the following symbols, shown here with their meaning: Please consult instructions for use Catalogue number IVD For in vitro diagnostic use Store at Use by/Expiry date Lot number 0088 Blood glucose meter and test strips: These products fulfil the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. 0088 This booklet consists of four parts.
Contents The Accu-Chek Integra meter is intended for use by one person only. Use of the same Accu-Chek Integra meter by more than one person or for performing blood glucose measurements in more than one person poses an infection risk. Any object coming into contact with human blood is a potential source of infection (see: National Committee for Clinical Laboratory Standards: Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue.
Contents 5 6 Using the Accu-Chek Integra meter as an electronic notebook 5.1 Memory 5.2 Viewing test results 5.3 Highest value, lowest value, average 5.4 Downloading data to a PC or handheld computer Contents 11 Introduction 11.1 Your lancing device at a glance 11.2 About the Accu-Chek Softclix lancing device 100 100 102 65 12 Using the Accu-Chek Softclix lancing device 12.1 Inserting or exchanging the lancet 12.2 Preparations for taking blood 12.3 Obtaining blood 12.
Contents Contents Part 3 Accu-Chek Softclix AST Accessory Instructions for Use Part 4 Appendix 16 System components 122 13 Introduction 13.1 A new way to test 13.2 Important information for users 110 110 113 17 Guarantee 123 18 Patents 123 14 AST testing 14.1 Preparing for AST testing 14.2 Measuring blood glucose 116 116 119 19 Local customer support and service 19.1 Information and repair 19.
Part 1 ACCU-CHEK Integra BLOOD GLUCOSE METER User’s Manual 8 ®
1 Introduction 1.1 Your blood glucose meter at a glance SET button Press this button to enter the Set menu and change the settings. Display window ON/OFF button Press this button only if you want to test your blood glucose or to turn the meter off. Drum compartment release button Drum compartment Test strip drum Test strip Optical system Optical system cover* MEMO button Press this button to view results stored in the meter’s memory.
1.
1.2 Main features With your Accu-Chek Integra blood glucose meter you can test your blood glucose simply and with confidence. Test strip drum instead of individual test strips You never need to touch a test strip. Simply insert a drum with 17 test strips into the Accu-Chek Integra meter. Easy to operate Turn on the meter, apply blood, read the result, press the button to eject the test strip. Automatic coding Every test strip drum has its own bar code.
1.3 About this manual This manual will help you get to know your new Accu-Chek Integra meter step by step. It will provide you with all the information you need to operate, troubleshoot, and care for your meter. It is important to remember that, in order to keep your meter in tip-top condition, you need to comply with all instructions given in addition to following the correct operating procedures. The Accu-Chek Integra meter is a precision instrument. Improper treatment can impair its function.
2 Initial steps before testing 2.2 2.1 Checking the contents Blood glucose results can be displayed in two different units (mmol/L or mg/dL). Consequently, Roche sells two different versions of the same meter. Check that your meter displays the unit you are accustomed to. On the back of your meter you will find the unit for which your instrument is coded. Ask your doctor if you do not know which is the right unit for you. The setting cannot be changed.
2.3 Inserting or replacing batteries If the meter is on, turn it off. Remove any used batteries. Press lightly on the lid of the battery compartment and slide it in the direction of the arrow (1). Insert two batteries (type AAA, LR 03, AM 4 or Micro). Make sure that the minus (-) pole of the battery is next to the minus contact in the battery compartment. Open the battery compartment (2).
2.3 Inserting or replacing batteries Fold the lid of the battery compartment down and slide it closed again. There will be an audible CLICK as it closes. After you have inserted the batteries, the meter turns on and the motor inside runs for about 10 seconds. A meter already containing a test strip drum then automatically turns off. i A new set of batteries provides enough power to carry out a minimum of 500 blood glucose tests. i Do not use rechargeable batteries.
2.3 i Inserting or replacing batteries When you replace the batteries, your stored results are retained in memory. However, you will need to re-enter the time and date. If you fail to do so, any blood glucose test results you obtain from this point forward will be displayed and saved without time and date. In this case, the test results saved in memory will be numbered consecutively so you can still see the order in which you took the readings. Never throw batteries into a fire.
2.4 2.5 Performing a full display test Release the MEMO button. Read the package insert that came with the test strip drums. The standard display test screen that is shown each time the meter is turned on appears briefly. When it disappears, the meter is in memory. If no results have yet been saved, three bars are displayed. mmol/L MEMO CTRL Standard display test i Inserting or replacing the test strip drum If the meter is on, turn it off.
2.5 Inserting or replacing the test strip drum Slide the release button on the right side of the meter in the direction indicated by the arrow. The drum compartment opens. To exchange the drum, first tip the meter upright. The old drum drops out. i 28 You can dispose of used drums with your regular household waste.
2.5 Inserting or replacing the test strip drum Insert the new test strip drum. Close the drum compartment. The meter automatically moves the drum to the correct position and reads the code on the drum. A dot appears in the small control window on the reverse side of the meter. This dot indicates that you have just inserted a drum. When you perform a blood glucose test, the meter counts the number of test strips that have been used and displays the number of strips remaining.
2.5 Inserting or replacing the test strip drum Use only new test strip drums on which the aluminium foil (the “silver ends”) is intact on both sides. Your blood glucose test results may be incorrect if damaged drums are used in the meter. Incorrect results can cause the wrong therapeutic decision to be taken and so produce adverse health effects. i i Handle the test strip drums with extreme care! Only remove a test strip drum from its container when you intend to use it.
2.5 Inserting or replacing the test strip drum When you insert a new drum the number of days the drum has been in the meter is counted automatically. Each drum must be used up within a 90-day use-by period. The drum symbol and “CTRL” flash in the display. CTRL After 90 days the date, the drum symbol and “CTRL” flash in the display. CTRL The drum has been in the meter for 90 days. You are asked to perform a quality control test in order to check the test strips.
3 Basic settings You may now move to the SET menu to turn the beep tone on or off, to set the year, time and date, and to define the time and date format.
3.1 Turning the beep tone on or off With the beep tone turned on, the meter beeps when it asks you to apply blood or control solution, when it starts to test, as confirmation that the test strip has received a sufficient amount of blood or control solution, when the result is displayed each time it displays a message. Check the meter is off. Press the MEMO button to turn off the beep tone. “OFF” appears in the display. If you press the MEMO button again, “ON” reappears.
3.2 Setting the year If you have a new meter or you have just replaced the batteries, the date will be set to 00.00.2000, and the time to 00:00 hours (24-hour format) or 12:00 a.m. (12-hour format). The correct time and date are needed to enable you to unambiguously identify your blood glucose test results, perform statistical analysis and to transfer them from your meter’s memory to a computer (see Chapter 5.4 “Downloading data to a PC or handheld computer”). Check the meter is off.
3.3 Changing the time/date format You can choose between the 24-hour format (0:00 to 23:59), in which case the date format is DD-MM (day followed by month), and the 12hour format (1 to 12 o’clock with a.m. or p.m.). In the latter case the date format changes to MM-DD (month followed by day). If you wish to set the time, leave the meter turned on and proceed to the next section, 3.4. If not, press the ON/OFF button to turn the meter off. The current settings will be saved automatically.
3.4 Setting the time Check the meter is off. Press the SET button. The meter turns on without advancing a test strip from the drum. Press the SET button again. The minute field flashes. Press the SET button repeatedly until the hour field flashes. Press the MEMO button repeatedly to set the minute. Press the MEMO button repeatedly to set the hour. If you hold the MEMO button down, the meter fast-scrolls forward to 59 and then begins again at 0.
3.5 Setting the date Check the meter is off. Press the SET button. The meter turns on without advancing a test strip from the drum. Press the SET button repeatedly until the month field flashes. 24-hour format: DD-MM 12-hour format: MM-DD Press the SET button again. The day field flashes. 24-hour format: DD-MM 12-hour format: MM-DD Press the MEMO button repeatedly to select the correct day. Press the MEMO button repeatedly to select the correct month.
4 Testing blood glucose The Accu-Chek Integra meter is intended for use by one person only. Wash your hands thoroughly with warm water and soap and dry them well. Use of the same Accu-Chek Integra meter by more than one person or for performing blood glucose measurements in more than one person poses an infection risk. Open the display cover. Press the ON/OFF button. The meter turns on.
4 Testing blood glucose Wait until the flashing hand and blood drop symbol appear in the display and the meter beeps (provided the beep tone is turned on). The following messages appear in turn on the display. mmol/L MEMO CTRL Standard display test mmol/L A test strip is being advanced mmol/L You may now apply blood The standard display test takes about 2 seconds. Check that all the segments making up the numerals are properly displayed.
4 Testing blood glucose Touch the blood drop against the front edge of the test strip near the black notch without delay. The strip draws up the blood. As soon as a sufficient amount of blood has been drawn up, the meter beeps and the test commences automatically. 000 appears in the display at the start of the test. If the test does not commence, you did not apply sufficient blood. You can then apply more blood (see the package insert that came with the test strip drum).
4 Testing blood glucose Hold the meter upright over a waste bin. Press the ON/OFF button. The meter turns off and the used test strip falls out. i If you do not turn off the meter, it turns off automatically after about 60 seconds. The test strip then remains in the meter. When you turn on a meter still containing a used test strip, this is merely ejected and the meter automatically turns off again. i Always let the meter eject the test strip.
4.1 Plausible results Your Accu-Chek Integra meter measures blood glucose within a defined range (0.6-33.3 mmol/L). Values below this range are displayed as: Your blood glucose result is below 0.6 mmol/L. Values above this range are displayed as: Your blood glucose result is above 33.3 mmol/L. These values are not used for statistical calculations (see Chapter 5.3 “Highest value, lowest value, average”). If the test result agrees with the way you feel, follow your doctor’s advice.
5 Using the Accu-Chek Integra meter as an electronic notebook 5.2 5.1 Memory With the meter turned off, press the MEMO button. The meter turns on without advancing a test strip from the drum. The most recent test result and “MEMO” are displayed. Your Accu-Chek Integra meter has a 100-value memory for saving results together with time and date (provided the latter are correctly set). You do not need to save a result specially, the meter does it all for you.
5.3 Highest value, lowest value, average Your meter can display the highest and lowest blood glucose results and the average (or mean) of current test results. Statistics are based on the test results stored for the last 7 days, as long as they were saved with the date and time. If more than 100 tests were carried out during this period, statistics will be based on the last 100. Press the MEMO button again. The highest measured test result is displayed together with the time and date.
5.4 Downloading data to a PC or handheld computer Your Accu-Chek Integra meter has an inbuilt infrared interface permitting cordless data downloading to a suitably equipped PC or handheld computer. All results in memory are downloaded each time. Install the software according to the manufacturer’s instructions. For data downloading you need a suitable PC program as well as the Accu-Chek Infrared Cable. Roche Diagnostics offers a variety of special software programs (e.g.
5.4 Downloading data to a PC or handheld computer Press the SET button and MEMO button at the same time. The meter turns on without advancing a test strip from the drum. Two arrows appear in the display. The meter automatically downloads all stored blood glucose test results to your computer. The two arrows flash in the display during the download. Once downloading has finished, the meter turns off automatically. A message is displayed on the computer indicating that the data transfer is complete.
6.2 Performing a quality control check Read the package insert that came with the control solutions. Press the ON/OFF button. The meter turns on. You now have approximately 5 minutes in which to apply control solution. After this time the meter automatically turns off. This strip can no longer be used. If this occurs, press the ON/OFF button to eject the test strip. Start the quality control check again with a new test strip.
6.2 i Performing a quality control check The control solution you apply to the test strip must come from a suspended drop. Do not apply control solution that has trickled down the outside of the dropper, as this will possibly generate results that are too high. As soon as a sufficient amount of control solution has been drawn up, the meter beeps and the test commences automatically. 000 appears in the display at the start of the test and gradually disappears while the test is running.
6.2 Performing a quality control check If you are unable to identify or eliminate the source of the problem please contact Customer Support (see Chapter 19 for details). Hold the meter upright and press the ON/OFF button. The used test strip falls out at the bottom. i Control readings (identified by “CTRL”) are not used in statistical calculations.
7 Cleaning the Accu-Chek Integra meter Clean the meter carefully, if the test strip guide has become visibly soiled, the message OFF is displayed (see page 92). Clean the small window covering the optical system, its surroundings and the test strip guide carefully with a lightly moistened cotton swab or a soft, lint-free cloth. Remove the cover from the measurement optics by slightly squeezing it from both sides (1) and lifting it off (2).
7 Cleaning the Accu-Chek Integra meter Make sure that no liquid enters the meter itself and avoid scratching the measurement optics, as this will impair the measuring function. When all of the components are thoroughly dry, check that the meter is clean (no lint or fluff remaining). Place the optics cover back in position from above. Press on the left and right sides of the cover. The cover quietly clicks back into place.
8.1 Temperature range A test can be performed at the limits of the permitted range (between +5 °C and +10 °C or between +40 °C and +45 °C), but the result should be interpreted with caution and should not be used as a basis for making therapeutic decisions. A thermometer symbol ( ) flashes in the display. Tests cannot be performed at temperatures outside the permitted range (below +5 °C or above +45 °C). The following message is displayed: 8.2 Keep the meter at below 85 % relative humidity.
9 Display messages and troubleshooting When you use your Accu-Chek Integra meter, various letters and symbols will appear on the display and also at times error messages. Some of the routine display messages have already been explained. Following is a complete list of display messages, what they mean, and what action you should take in case you see an error message. Please watch out for any messages displayed when you use the meter. Every message provides you with important information.
9.1 Messages and symbols This message/ symbol appears ... and means: This message/ symbol appears ... The test is in progress. and means: You are requested to run a quality control test. CTRL This is/was a quality control test. CTRL The temperature during testing is at the limits of the permitted range (between +5 °C and +10 °C or between +40 °C and +45 °C). MEMO indicates a value saved in memory. Do not use the result as a basis for therapeutic decisions.
9.1 Messages and symbols This message/ symbol appears ... and means: The battery is running low. When this symbol first appears, you can perform approximately a further 50 tests. Continue testing until all the test strips in the test strip drum have been used. Then insert two new batteries (type AAA) and a new test strip drum. When the batteries are so weak that no more tests can be performed, the battery symbol appears briefly for 3 seconds in the display. Then the meter turns off.
9.2 Troubleshooting When symbols and numbers are surrounded by a halo, it indicates that they are flashing in the meter’s display. If this happens ... The meter is turned on, but the display remains blank. The display is defective. Clock has stopped or clock is slow after the meter is turned on. The meter was exposed to temperatures below -10 °C and the batteries are starting to freeze. Turn the meter off. Let the meter slowly warm up.
9.2 Troubleshooting This message/ symbol appears ... and means: You inserted a test strip drum that has already been used. You opened the drum compartment. You changed the batteries without changing the test strip drum at the same time. You performed the requested quality control check and flagged it as such. The bar code information from the test strip drum has been lost. Turn the meter off. Open the drum compartment and close it again. The meter then rotates the drum and reads the bar code.
9.2 Troubleshooting This message/ symbol appears ... and means: If you inserted the second or third drum from a pack, press the SET button. The meter uses the bar code from the first drum. The error message “E-2” disappears. The drum symbol and “CTRL” flash in the display, requesting you to perform a quality control check. You can use all 17 test strips. The drum symbol continues to flash in the display until a new drum is inserted.
9.2 Troubleshooting This message/ symbol appears ... and means: This message/ symbol appears ... and means: A test error has occurred. The test strip is stuck in the guide. Turn the meter off and on again. Repeat the test. Turn the meter off. Pull the strip out of the meter. Open the drum compartment and remove the drum. Reinsert the drum and close the drum compartment. The drum symbol and “CTRL” flash in the display when the meter is turned on. Perform a quality control check.
9.2 Troubleshooting This message/ symbol appears ... and means: You applied the blood drop or control solution drop too soon. Turn the meter off and on again. Repeat the test. Wait until the flashing hand symbol and blood drop symbol appear in the display and the meter beeps (provided the beep tone is turned on) before applying blood or control solution. The optical system is dirty. Clean the optical system (see Chapter 7 “Cleaning the Accu-Chek Integra meter”) and repeat the test.
9.2 10 Troubleshooting This message/ symbol appears ... Technical data Meter type Accu-Chek Integra Catalogue number/serial number See type plate on the back of the meter. Test principle Determination of glucose in fresh capillary blood by reflectance photometry. When using different specimen material please refer to the package insert that came with the Accu-Chek Integra test strip drums. Measuring range 0.6–33.3 mmol/L (10–600 mg/dL) Sample size Approx. 1.
10 Technical data Humidity Less than 85 % relative humidity Memory capacity 100 test results with time and date, average, highest and lowest blood glucose reading Dimensions 103 x 52 x 31 mm Weight Approx.
Part 2 ACCU-CHEK Softclix Lancing Device Instructions for Use 98 ®
11 Introduction A B 11.
11.2 About the Accu-Chek Softclix lancing device 12 Using the Accu-Chek Softclix lancing device The Accu-Chek Softclix lancing device is an easy-to-use lancing device that has been specially developed to allow virtually pain-free collection of capillary blood from a fingertip or earlobe. 12.1 Inserting or exchanging the lancet Pull off the cap. The depth of lancet penetration can be precisely adjusted to suit individual skin requirements.
12.1 Inserting or exchanging the lancet 12.2 Preparations for taking blood Press the cap on again until it clicks. Be sure to align the notch on the cap with the centre of the semi-circular cut-out on the ejector. The best place for obtaining capillary blood is from a fingertip or an earlobe. We recommend using the side of a fingertip, as this registers least pain. To avoid infection, use a new lancet each time you take blood. Using each lancet once only helps ensure virtually pain-free blood sampling.
12.3 Obtaining blood First check that you have set the desired penetration depth. Press in the priming button until it clicks. Be careful not to press the release button at the same time. The lancing device is primed when a yellow dot appears in the transparent release button. Gently press the lancing device against the fingertip or earlobe and press the release button, taking care not to push against the priming button or to impede its free movement.
Part 3 ACCU-CHEK Softclix AST ACCESSORY Clear plastic AST cap for blood glucose determination with Accu-Chek Integra on alternative sites Instructions for Use 108 ®
13 Introduction 13.1 A new way to test Traditionally, blood samples for blood glucose testing are taken from the fingertip or from the earlobe. With the Accu-Chek Integra system, you now also have the option of using capillary blood samples from other sites, such as the base of the thumb, the forearm, the upper arm or the calf. Testing with blood from these alternative sites is referred to as Alternative Site Testing (AST). Blood from the fingertip can be used for testing at any time.
13.1 A new way to test 13.2 Important information for users Alternative Sites for Testing Before you perform a test with blood from an alternative site, you should be aware of the following limitations: Capillary blood from the fingertip responds more quickly to changes in blood glucose levels than blood from alternative sites. Blood glucose values measured in blood taken from these sites may therefore differ from values measured in blood from the fingertip.
13.2 Important information for users If you are considering AST for your glucose measurements, please discuss this first with your healthcare professional. Pre-test Checklist If the displayed blood glucose result does not match how you feel, you should do a fingertip test to check the result. If the fingertip result still does not match how you feel, contact your doctor. Do not change your treatment decisions based on just one AST result.
14 AST testing 14.1 Preparing for AST testing 1. Remove the blue cap from the Accu-Chek Softclix lancing device. 2. Insert a new Accu-Chek Softclix lancet into the lancet holder and push it in until it clicks. Remove the protective cap from the lancet with a twisting motion. 3. Now place the clear plastic AST cap on the device and press until it clicks. Set the penetration depth to the highest setting (5.5). (For AST on the base of the thumb a setting of 3-4 is often sufficient.
14.1 Preparing for AST testing 5. Choose a fleshy area of the alternative site and wash it with warm, soapy water or use an alcohol wipe. Ensure that the skin is dry before taking a blood sample. As an example you can use the top side of your forearm, approximately 5 cm below the elbow. 6. Firmly press the clear AST cap against the selected site. Press the release button and continue to apply pressure to the site for a couple of seconds. You can watch the drop of blood form through the clear cap.
15 Cleaning the Accu-Chek Softclix lancing device and the AST Cap Clean the lancing device weekly using a cloth moistened with soapy water or 70 % alcohol (available in pharmacies). In addition, thoroughly wipe the inside of the blue cap and the clear AST cap using a cotton bud moistened with 70 % alcohol. Allow the lancing device and the two caps to dry thoroughly before performing a new test. Part 4 ACCU-CHEK Integra Notes: Do not prime the device until you are ready to take blood.
16 System components With your Accu-Chek Integra meter use only Accu-Chek Integra test strip drums. The drums contain 17 test strips. Each drum comes individually packaged in its own container. The test strip drums are available from your pharmacist or Diabetes Australia. For quality control checking of your Accu-Chek Integra meter use only Accu-Chek Integra Control solutions (see Chapter 6 “Checking the Accu-Chek Integra meter”).
19 Local customer support and service 19.2 Contact us 19.1 Information and repair Accu-Chek Enquiry Line: Freecall 1800 251 816 Information service If you have any questions on how to use your Accu-Chek Integra meter or Accu-Chek Softclix lancing device or the AST cap, if any of the results you obtain seem implausible, or if you suspect the meter or lancing device have a fault, please contact customer support and service. See the next chapter for details. Roche Diagnostics Australia Pty Ltd.
20 Alphabetical index A Alternative sites .............................................................................. 112 Alternative site testing ................................................................ 109 ff. AST cap ...................................................................... 117 ff., 120, 122 Average .................................................................................. 60, 86 ff. B Bar code ...........................................................................
20 Alphabetical index E L Electromagnetic interference ............................................................ 77 Error messages ............................................................................ 84 ff. Expiry date, test strips ...................................................................... 31 Lancet ................................................................. 100, 103 f., 106, 122 Lancing device ................................................................... 100 ff.
20 Alphabetical index O S ON/OFF button .................................................................................. 10 Optical system .................................................................................. 10 Optical system, cleaning the optical system .................................. 71 ff. Optical system, opening the optical system ....................................... 72 Sample size ................................................................................
T Technical data .............................................................................. 95 ff. Temperature range .................................................................. 75 f., 95 Test strip drum, inserting or replacing ........................................... 27 ff. Test strip Ejection ................................................................................ 54 f. Guide ....................................................................................... 12 Symbol ............
