0 45 24 38 10 01 (0 3) 2 00 7- 05 0088 blood glucose monitoring system complete instructions for use farbe: pms 583 – prüfmittelnummer: 208 a ccu- c hek ® integra accu-chek, accu-chek integra and softclix are trademarks of roche. Roche diagnostics australia pty ltd. 31 victoria avenue castle hill, n...
1 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 sym- bols, shown here with their meaning: please consult instructions for use catalogue number ivd for in vitro diagnostic use store at use by/expiry date lo...
2 farbe: pms 583 – prüfmittelnummer: 208 3 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 ...
4 farbe: pms 583 – prüfmittelnummer: 208 5 contents 5 using the accu-chek integra meter as an electronic notebook 58 5.1 memory 58 5.2 viewing test results 59 5.3 highest value, lowest value, average 60 5.4 downloading data to a pc or handheld computer 62 6 checking the accu-chek integra meter 65 6....
6 farbe: pms 583 – prüfmittelnummer: 208 7 contents part 3 accu-chek softclix ast accessory instructions for use 13 introduction 110 13.1 a new way to test 110 13.2 important information for users 113 14 ast testing 116 14.1 preparing for ast testing 116 14.2 measuring blood glucose 119 15 cleaning ...
8 farbe: pms 583 – prüfmittelnummer: 208 part 1 a ccu- c hek ® integra blood glucose meter user’s manual.
10 farbe: pms 583 – prüfmittelnummer: 208 11 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 c...
12 farbe: pms 583 – prüfmittelnummer: 208 13 1.1 your blood glucose meter at a glance battery compartment cover* type plate infrared window battery compartment batteries: type aaa, lr 03, am 4, micro test strip guide control window (shows the number of strips remaining) * available as replacement pa...
14 farbe: pms 583 – prüfmittelnummer: 208 15 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 ...
16 farbe: pms 583 – prüfmittelnummer: 208 17 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 re- member that, in orde...
18 farbe: pms 583 – prüfmittelnummer: 208 19 2 initial steps before testing 2.1 checking the contents check that your accu-chek integra blood glucose monitoring kit is com- plete. The package contents are listed on the box. If anything is missing, please contact customer support (see chapter 19 for ...
20 farbe: pms 583 – prüfmittelnummer: 208 21 2.3 inserting or replacing batteries if the meter is on, turn it off. Press lightly on the lid of the battery compartment and slide it in the direction of the arrow (1). Open the battery compartment (2). Remove any used batteries. Insert two batteries (ty...
22 farbe: pms 583 – prüfmittelnummer: 208 23 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 seco...
24 farbe: pms 583 – prüfmittelnummer: 208 25 2.3 inserting or replacing batteries i 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 forwar...
26 farbe: pms 583 – prüfmittelnummer: 208 27 2.4 performing a full display test release the memo button. 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 disp...
28 farbe: pms 583 – prüfmittelnummer: 208 29 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 you ca...
30 farbe: pms 583 – prüfmittelnummer: 208 31 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 reve...
32 farbe: pms 583 – prüfmittelnummer: 208 33 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 result...
34 farbe: pms 583 – prüfmittelnummer: 208 35 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. After 90 days the date, the drum symbol and “ctr...
36 farbe: pms 583 – prüfmittelnummer: 208 37 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. When you turn on your accu-chek integra meter for the first time, it has the following settings (whi...
38 farbe: pms 583 – prüfmittelnummer: 208 39 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 solutio...
40 farbe: pms 583 – prüfmittelnummer: 208 41 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 un...
42 farbe: pms 583 – prüfmittelnummer: 208 43 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 12- hour format (1 to 12 o’clock with a.M. Or p.M.). In the latter case the date format ch...
44 farbe: pms 583 – prüfmittelnummer: 208 45 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 repeatedly until the hour field flashes. Press the memo button repeatedly to set the hour. 24-hour for...
46 farbe: pms 583 – prüfmittelnummer: 208 47 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 memo b...
48 farbe: pms 583 – prüfmittelnummer: 208 49 4 testing blood glucose 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 o...
50 farbe: pms 583 – prüfmittelnummer: 208 51 4 testing blood glucose the following messages appear in turn on the display. Standard display test a test strip is you may now being advanced apply blood the standard display test takes about 2 seconds. Check that all the segments making up the numerals ...
52 farbe: pms 583 – prüfmittelnummer: 208 53 as soon as a sufficient amount of blood has been drawn up, the meter beeps and the test commences automatically. 000 appears in the dis- play at the start of the test. If the test does not commence, you did not apply sufficient blood. You can then apply m...
54 farbe: pms 583 – prüfmittelnummer: 208 55 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 rem...
56 farbe: pms 583 – prüfmittelnummer: 208 57 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 blo...
58 farbe: pms 583 – prüfmittelnummer: 208 59 5 using the accu-chek integra meter as an electronic notebook 5.1 memory your accu-chek integra meter has a 100-value memory for saving re- sults together with time and date (provided the latter are correctly set). You do not need to save a result special...
60 farbe: pms 583 – prüfmittelnummer: 208 61 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...
62 farbe: pms 583 – prüfmittelnummer: 208 63 5.4 downloading data to a pc or handheld computer your accu-chek integra meter has an inbuilt infrared interface permit- ting cordless data downloading to a suitably equipped pc or handheld computer. All results in memory are downloaded each time. For dat...
64 farbe: pms 583 – prüfmittelnummer: 208 65 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 ...
66 farbe: pms 583 – prüfmittelnummer: 208 67 6.2 performing a quality control check read the package insert that came with the control solutions. Open the display cover. Press the on/off button. The meter turns on. Check during the standard display test that all the segments making up the numerals a...
68 farbe: pms 583 – prüfmittelnummer: 208 69 6.2 performing a quality control check i 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...
70 farbe: pms 583 – prüfmittelnummer: 208 71 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 ...
72 farbe: pms 583 – prüfmittelnummer: 208 73 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). Remove the cover from the measurement optics by slightly squeez- ing it from both sides (1) an...
74 farbe: pms 583 – prüfmittelnummer: 208 75 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 (...
76 farbe: pms 583 – prüfmittelnummer: 208 77 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 decision...
78 farbe: pms 583 – prüfmittelnummer: 208 79 9 display messages and troubleshooting when you use your accu-chek integra meter, various letters and sym- bols will appear on the display and also at times error messages. Some of the routine display messages have already been explained. Following is a c...
80 farbe: pms 583 – prüfmittelnummer: 208 81 this message/ symbol appears ... And means: the test is in progress. Memo memo indicates a value saved in memory. Memo no results have been saved. The meter cannot calculate the average value as memory only contains results that are not considered in the ...
82 farbe: pms 583 – prüfmittelnummer: 208 83 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...
84 farbe: pms 583 – prüfmittelnummer: 208 85 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 ... It means: meter will not turn on. Batteries are empty. Insert new batteries. Ambient temperature is too ...
86 farbe: pms 583 – prüfmittelnummer: 208 87 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 co...
88 farbe: pms 583 – prüfmittelnummer: 208 89 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” disap- pears. The drum symbol and “ctrl” flash in the display,...
90 farbe: pms 583 – prüfmittelnummer: 208 91 this message/ symbol appears ... And means: a test error has occurred. Turn the meter off and on again. Repeat the test. There was not enough blood or control solution on the test strip. Turn the meter off and on again. Repeat the test with a larger drop ...
92 farbe: pms 583 – prüfmittelnummer: 208 93 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...
94 farbe: pms 583 – prüfmittelnummer: 208 95 this message/ symbol appears ... And means: the meter and the infrared cable are too far away from one another or not correctly aligned. Decrease the distance between the infrared windows of the two devices to less than 10 cm. Make sure the two infrared w...
96 farbe: pms 583 – prüfmittelnummer: 208 97 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. 120 g with batteries and test strip drum display liquid crystal dis...
98 farbe: pms 583 – prüfmittelnummer: 208 part 2 a ccu- c hek ® softclix lancing device instructions for use.
100 farbe: pms 583 – prüfmittelnummer: 208 101 11 introduction 11.1 your lancing device at a glance a cap b comfort dial (for depth selection) c notch d protective cap e lancet f lancet holder g semi-circular cut-out h ejector i transparent release button j priming button tu rn ed through 1 80 ° a b...
102 farbe: pms 583 – prüfmittelnummer: 208 103 12 using the accu-chek softclix lancing device 12.1 inserting or exchanging the lancet pull off the cap. If there is already a lancet in the lancing device, slide the ejector forwards to remove it. Insert a new lancet in the lancet holder. And push it u...
104 farbe: pms 583 – prüfmittelnummer: 208 105 12.1 inserting or exchanging the lancet 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. To avoid infection, use a new lancet each time you take blood. Using each ...
106 farbe: pms 583 – prüfmittelnummer: 208 107 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 but- ton at the same time. The lancing device is primed when a yellow dot appears in the t...
108 farbe: pms 583 – prüfmittelnummer: 208 part 3 a ccu- c hek ® softclix ast accessory clear plastic ast cap for blood glucose determination with accu-chek integra on alternative sites instructions for use.
110 farbe: pms 583 – prüfmittelnummer: 208 111 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 s...
112 farbe: pms 583 – prüfmittelnummer: 208 113 13.1 a new way to test alternative sites for testing hand below the little finger hand below the thumb inside of the forearm upper arm outside of the forearm calf preferred alternative sites 13.2 important information for users before...
114 farbe: pms 583 – prüfmittelnummer: 208 115 13.2 important information for users if you are considering ast for your glucose measurements, please discuss this first with your healthcare professional. If the displayed blood glucose result does not match how you feel, you should do a fingertip test...
116 farbe: pms 583 – prüfmittelnummer: 208 117 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 w...
118 farbe: pms 583 – prüfmittelnummer: 208 119 14.1 preparing for ast testing 5. Choose a fleshy area of the alterna- tive 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,...
120 farbe: pms 583 – prüfmittelnummer: 208 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 c...
122 farbe: pms 583 – prüfmittelnummer: 208 123 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 ...
124 farbe: pms 583 – prüfmittelnummer: 208 125 19 local customer support and service 19.1 information and repair 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 implaus...
126 farbe: pms 583 – prüfmittelnummer: 208 127 20 alphabetical index a alternative sites .............................................................................. 112 alternative site testing ................................................................ 109 ff. Ast cap .........................
128 farbe: pms 583 – prüfmittelnummer: 208 129 e electromagnetic interference ............................................................ 77 error messages ............................................................................ 84 ff. Expiry date, test strips .....................................
130 farbe: pms 583 – prüfmittelnummer: 208 131 o on/off button .................................................................................. 10 optical system .................................................................................. 10 optical system, cleaning the optical system .........
132 farbe: pms 583 – prüfmittelnummer: 208 t technical data .............................................................................. 95 ff. Temperature range .................................................................. 75 f., 95 test strip drum, inserting or replacing ......................