ACCU-CHEK ® Active BLOOD GLUCOSE SYSTEM Reference Manual man_04493168001_02_EnUK.
Please read this manual carefully and completely before performing the first measurement. Should you have any questions, please contact our customer support and service centre. You will find our address in Chapter 10.4. The Accu-Chek Softclix finger pricker is intended for patient self-monitoring by a single person. It must not be used to collect blood in a multi-patient setting as it does not incorporate any features to guard against cross-infection.
Contents 1 2 3 | | | | | | | | | | | | | | | | | Introduction 1.1 The meter’s main features at a glance 1.2 About this reference manual 8 9 12 Modes 2.1 Test Mode 2.2 Memory Mode 2.3 Set Mode 14 15 16 17 Initial steps before testing 3.1 After opening the pack 3.2 Basic settings Turning the meter on in Set Mode Setting the date and time Setting the beep tone 3.3 Coding Inserting the coding chip 18 18 19 23 27 31 32 35 1 man_04493168001_02_EnUK.
Contents 4 5 6 | | | | | | | | | || | | | | | || | | | | | | Testing blood glucose with your Accu-Chek Active meter 4.1 Materials for testing blood glucose 4.2 Preparing for the blood glucose test 4.3 Performing a blood glucose test In-meter dosing Plausible results Implausible results Out-of-meter dosing Testing by healthcare professionals 36 36 37 38 44 49 52 55 59 Using Accu-Chek Active as an electronic diary 5.1 Results memory 5.
| | | | | | 8 | | | | | | 9 | | | | | 10 | | | | | 11 | 7 98 99 Keeping your meter in tip-top condition 7.1 Cleaning your Accu-Chek Active meter Cleaning and disinfection in the professional environment 7.2 Battery life and battery replacement 7.3 Measurement and storage conditions 104 106 109 Summary: All the display messages on your Accu-Chek Active meter 8.1 About the display messages 8.2 Messages and symbols 8.3 Troubleshooting 8.
Parts summary Accu-Chek Active 8 7 1 3 2 9 4 man_04493168001_02_EnUK.
Liquid crystal display (LCD) 1 M(emory) button 2 S(et) button 3 Test strip slot with switch 4 Measurement optics 5 Test strip guide 6 Battery compartment 7 Battery 8 Coding chip 9 1 5 4 6 5 man_04493168001_02_EnUK.
Parts summary Accu-Chek Active 10 6 man_04493168001_02_EnUK.
Coding chip slot 10 Infrared interface 11 11 7 man_04493168001_02_EnUK.
1 Introduction Your Accu-Chek Active blood glucose meter is a state-of-the art precision instrument that will enable you to test your blood glucose simply and with confidence. Before using your Accu-Chek Active meter or Accu-Chek Softclix finger pricker for the first time, please refer to the Getting Started Guide included in this pack. Should you require further information, please study this reference manual.
1.1 The meter’s main features at a glance 씰 Testing in record time: With a testing time of about 5 seconds, your Accu-Chek Active is one of the fastest blood glucose meters available. 씰 New design: Your new Accu-Chek Active was designed for good looks, and ergonomic functionality. 씰 Tiny blood sample: Your Accu-Chek Active requires only a tiny drop of blood – 1 to 2 µL – if you apply the blood drop to the middle of the test pad.
1.1 The meter’s main features at a glance 씰 Integrated data evaluation: From the results stored in memory your meter can calculate the average of your blood glucose results over the last 7 or 14 days. 씰 Out-of-meter dosing: After activating the test cycle you may remove the test strip to apply blood (e.g. from an earlobe), and then insert it again in the meter. 씰 Accurate results: Application of blood to the test strip starts a colour reaction.
씰 Easy-to-read display: Numbers and messages are clearly presented on a spacious display screen. Clear symbols give you additional easy-to-follow instructions. 씰 Intelligent power supply: Accu-Chek Active shuts off automati- cally after 1–2 minutes of non-use. Naturally, all of your results and other data remain safe in memory. Also, you receive a warning when the battery has only enough power for about another 50 tests. 11 man_04493168001_02_EnUK.
1.2 About this reference manual This manual will help you get to know your new Accu-Chek Active meter step by step. It will provide you with all the information you need to operate, troubleshoot, clean 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 the care instructions in addition to following the correct operating procedures. Accu-Chek Active is a precision instrument.
This symbol indicates that your meter is at risk of being damaged. This symbol highlights important information that will help you get the most out of your meter. We recommend that you start by familiarizing yourself with all of the elements of your Accu-Chek Active shown on pages 4–7 of this manual. Practise all of the operations described in this manual, and also practise testing. That way you can feel confident in testing whenever you need. 13 man_04493168001_02_EnUK.
2 Modes As you will have gathered, your Accu-Chek Active meter can do much more than just measure blood glucose. It offers a number of additional functions, which fall into three groups. “Mode” refers to a group of functions that you can call upon. You select a mode simply by turning on the meter or by the way in which you turn it on. Detailed information on the various ways of turning on your meter and the options available in each mode is provided later in this manual. 14 man_04493168001_02_EnUK.
2.1 Test Mode This is the main mode in which you will use your Accu-Chek Active meter and is used exclusively for testing your blood glucose. By inserting a test strip in the test strip guide, you automatically enter this mode. 15 man_04493168001_02_EnUK.
2.2 Memory Mode Memory Mode provides you with various functions to help you evaluate your results. To enter this mode, turn on your Accu-Chek Active meter by pressing the M(emory) button. 씰 You can retrieve up to 200 results. 씰 Your Accu-Chek Active meter can calculate the average of your glucose results over the last 7 or 14 days. 씰 You can download your results to a PC from the meter’s memory (Accu-Chek Compass software available separately). 씰 You can erase the most recent result.
2.3 Set Mode To enter Set Mode, turn on your Accu-Chek Active meter by pressing the S(et) button. 씰 You can choose the format in which you wish the date and time to be displayed. 씰 You can enter the date and time (required once only). 씰 You can enable and disable the beep tone. 17 man_04493168001_02_EnUK.
3 Initial steps before testing 3.1 After opening the pack Accu-Chek Active is sold complete with one lithium battery already inserted. A plastic film protects the battery against becoming drained prematurely. Before using the meter, remove the film covering the battery. 씰 The film is visible at the top of your Accu-Chek Active meter, projecting from the battery compartment. Simply pull the film directly away from the top of the meter. 씰 This will open the battery compartment.
3.2 Basic settings When you turn on your Accu-Chek Active meter for the first time, it has the following settings (which you can change): 씰 Display format for the date: day.month/DD.MM (or alternatively month.day/MM-DD) 씰 Display format for the time: 24h (or alternatively 12h) 씰 Year: year of manufacture 씰 Date: 0.0 (or alternatively 0-0) 씰 Time: 0:00 (or alternatively 0:00 a.m.) 씰 Beep tone: on 19 man_04493168001_02_EnUK.
3.2 Basic settings Accu-Chek Active comes in 2 versions. When you first turn on your Accu-Chek Active, please be sure to check that the meter is set to display mmol/L (for millimoles per litre) above the large numerals in the display (888). Ask your doctor if you do not know which is the right unit for you. If this is not displayed, please contact the Accu-Chek Customer Careline free on 0800 701000 (UK) or 1 800 709600 (Ireland) for a replacement meter. 20 man_04493168001_02_EnUK.
If you see the correct unit, please enter the date and time as described. Only then can your results be properly saved in “memory” with the correct date and timestamp. 21 man_04493168001_02_EnUK.
3.2 Basic settings 22 man_04493168001_02_EnUK.
Turning the meter on in Set Mode You use only the M and S buttons on the front of your Accu-Chek Active to enter the desired settings. 씰 Briefly press the S button (for less than 3 seconds). Accu-Chek Active is now turned on and in Set Mode. In the display you see the following: 씰 the current time display format (24h/12h) 씰 flashing: the current time, or 0:00 (a.m.) when you turn on the meter for the first time 씰 flashing: the current date, or 0.
3.2 Basic settings 24 man_04493168001_02_EnUK.
The way in which the date and time are displayed from here on depend on the chosen display format. 씰 If you wish to change the time display format, press the M button now. This allows you to choose between 24h and 12h display format. 씰 When you see the desired format, press the S button once to proceed to the date and time settings. 25 man_04493168001_02_EnUK.
3.2 Basic settings 26 man_04493168001_02_EnUK.
Setting the date and time The procedure for setting the date and time is essentially the same for all units of time (day, hour, etc.): 씰 Use the S button to select the unit of time you wish to change. The unit will flash, indicating that it is ready to be changed. 씰 Use the M button to modify the unit of time selected. 씰 Pressing the M button once will increment the value of the unit by one (one hour, one minute, etc.).
3.2 Basic settings 28 man_04493168001_02_EnUK.
씰 Confirm the setting by pressing the S button again. The display moves on automatically to the next unit of time, which again flashes. 씰 Use the same procedure to set all the remaining units of time. The date and time are set in the following sequence: hours –> minutes –> year –> month –> day The year is already set. Press the S button to confirm. The meter automatically recognises, and allows for, leap years. 29 man_04493168001_02_EnUK.
3.2 Basic settings 30 man_04493168001_02_EnUK.
Setting the beep tone After you have set the day and pressed the S button, you can either enable or disable the beep tone. 씰 Press the M button to turn the beep tone on and off. 씰 Press the S button to complete the settings procedure. Check that all the settings now shown on the display are correct. Press the S button again to turn off your Accu-Chek Active meter. If any of the settings are incorrect, you may repeat the settings procedure (after turning the meter on again). 31 man_04493168001_02_EnUK.
3.3 Coding The properties of the Accu-Chek Active test strips you use with the meter may differ very slightly from one pack to another (because of batch-to-batch differences). Your Accu-Chek Active meter must be programmed to allow for these differences in properties in a process known as “coding”. All the information relating to the strips in a particular pack of Accu-Chek Active test strips is held in the coding chip that comes with that pack. 32 man_04493168001_02_EnUK.
Each time you open a new pack of test strips, you will need to insert the coding chip that came with that pack into your meter. Coding chips from other packs contain the wrong information for your new strips, so test results will be incorrect. Leave the coding chip in the meter until you have used up all of the test strips from a particular pack. Check that the three-digit code (e.g.133) printed on the chip matches the code printed on the label of the container the test strips came in.
3.3 Coding 34 man_04493168001_02_EnUK.
Inserting the coding chip When coding, leave your Accu-Chek Active meter turned off. 씰 Take the new coding chip from the pack of test strips. 씰 Gently slide the coding chip into the slot on the side of the meter ➉ (see parts summary). 씰 Ensure that you push the coding chip fully home.
4 Testing blood glucose with your Accu-Chek Active meter 4.1 Materials for testing blood glucose Please have the following items ready to carry out the test: 씰 your Accu-Chek Active meter with the coding chip inserted, 씰 the pack of Accu-Chek Active test strips you took the coding chip from, 씰 a suitable finger pricker (such as the Accu-Chek Softclix finger pricker and Accu-Chek Softclix Lancet). With your Accu-Chek Active meter use only Accu-Chek Active test strips.
4.2 Preparing for the blood glucose test If you are not yet familiar with the concept of blood glucose selfmonitoring using a meter, practise first by carrying out a quality control test as described in Chapter 6. A quality control test is carried out in the same way as a normal test, but with control solution (a standardized glucose solution) instead of blood. 씰 Carefully read the pack inserts that came with the test strips and the finger pricker.
4.3 Performing a blood glucose test 38 man_04493168001_02_EnUK.
Check the round control window on the back of the test strip with the colour scale printed on the test strip container. The colour of the control window must match that of the colour interval at the top (0 mmol/L). If the test strip shows a different colour, do not use it. Hold the test strip so that the application area and arrows are facing upwards. Gently push the test strip in the direction of the arrows into the test strip slot ➃ of your meter, until you hear it click into place.
4.3 Performing a blood glucose test 40 man_04493168001_02_EnUK.
씰 The meter carries out a display test (for details see page 87), then shows the code number. Is this the number printed on the test strip container? If not, check that you really did insert the coding chip from the new pack. If you are using the right coding chip but the number in your display is wrong, please call the Accu-Chek Customer Careline free on 0 800 701000 (UK) or 1 800 709600 (Ireland).
4.3 Performing a blood glucose test 42 man_04493168001_02_EnUK.
씰 Check that the correct date and time are displayed. Do not carry out any tests if the code number in the display is not the same as the number on the test strip pack. Incorrect coding produces incorrect results. Sometimes the error can be significant, causing the wrong therapeutic decision to be taken and so producing adverse health effects. When the display test has been successfully completed and the code number matches, your Accu-Chek Active meter is ready for testing.
4.3 Performing a blood glucose test In-meter dosing If you have opted for in-meter dosing, proceed as follows: 씰 Massage a fingertip to stimulate the circulation and make blood collection easier. 씰 Use the finger pricker to prick the side of the massaged fingertip. 씰 Without pressing too hard, encourage a small drop of blood to form. 44 man_04493168001_02_EnUK.
씰 Apply the drop of blood on to the middle of the orange-coloured, square application area (pad). It is OK to touch this area when applying blood, but do not attempt to spread the blood. If you suspect the amount of blood may not suffice, you may apply a second drop within 5 seconds. 씰 Your Accu-Chek Active meter beeps briefly (provided the beep tone is enabled) to acknowledge application of blood and to announce the start of testing.
4.3 Performing a blood glucose test 46 man_04493168001_02_EnUK.
씰 The hourglass symbol indicates that testing is in progress. 씰 The meter beeps again after about 5 seconds to signal that the test is complete. The result appears in the display and is automatically saved together with the date and time. 씰 Remove the test strip from the meter, which will now automatically turn off. 47 man_04493168001_02_EnUK.
4.3 Performing a blood glucose test 48 man_04493168001_02_EnUK.
Plausible results Your Accu-Chek Active meter measures blood glucose within a defined range (0.6-33.3 mmol/L). Values outside this range are displayed as “Lo”- meaning the result is less than 0.6 mmol/L or “Hi”- meaning the result is greater than 33.3 mmol/L. If you applied too little blood, please repeat the test with a new test strip. Now perform a plausibility check. It is important that this check be performed within 30–60 seconds after blood was applied.
4.3 Performing a blood glucose test 50 man_04493168001_02_EnUK.
씰 Turn over the test strip to reveal the round control window on the back. 씰 On the label of the test strip container is a colour scale with blood glucose values printed alongside. Select the blood glucose value that best approximates the reading you obtained. 씰 Compare the colour of the control window with the colour you selected on the label. The colours must be a fairly close match. If there is a great disparity, repeat the test.
4.
씰 Was the test strip container you are presently using kept properly closed? 씰 Have the test strips expired? 씰 Have the test strips been kept under suitable temperature conditions (i.e. not in a car in very hot or cold weather)? If the answer to all these questions is “yes”, carry out a quality control check with a new test strip as described in Chapter 6. If this check confirms the meter is working properly, please read the instructions in Chapter 4.
4.3 Performing a blood glucose test 54 man_04493168001_02_EnUK.
Out-of-meter dosing The test procedure is mostly identical with “Performing a blood glucose test” on page 38. Follow the instructions given there up to the point where you are instructed to apply blood. 씰 Clean and massage the site you intend to collect blood from (for example, an ear lobe). This will stimulate the circulation and make blood collection easier. 씰 Use the finger pricker to prick the selected site. 씰 Without pressing too hard, encourage a drop of blood to form. 55 man_04493168001_02_EnUK.
4.3 Performing a blood glucose test 씰 Pull the strip out of the meter. The two symbols (blood drop and test strip) are flashing. You now have 20 seconds to apply blood to the test strip and re-insert it before the meter switches off. After 15 seconds a beep tone once per second indicates that the time for measurement has expired. 56 man_04493168001_02_EnUK.
씰 Apply the drop of blood to the middle of the orange-coloured pad. It is OK to touch this application area when applying blood, but do not attempt to spread the blood. 씰 Gently push the test strip back into the test strip slot of your Accu-Chek Active meter, until you feel it click into place. 씰 Your Accu-Chek Active meter beeps briefly to acknowledge application of blood and to announce the start of testing.
4.3 Performing a blood glucose test 58 man_04493168001_02_EnUK.
씰 The meter beeps again after about 10 seconds to signal that the test is complete. The result appears in the display and is automatically saved together with the date and time. Testing by healthcare professionals The out-of-meter dosing feature of the Accu-Chek Active meter makes it ideal for testing in a professional environment. For each patient use a separate lancet and finger pricker, or alternatively use the specially developed Accu-Chek Softclix Pro, or Safe-T-Pro lancet devices.
5 Using Accu-Chek Active as an electronic diary 5.1 Results memory Your Accu-Chek Active meter has a 200-value memory for saving results together with date and time. You do not need to save a result specially; the meter does it all for you. Once all the memory locations are full, the meter automatically erases the oldest entry. All results in memory are consecutively numbered from 1 (most recent) to a maximum of 200 (oldest). 60 man_04493168001_02_EnUK.
In addition to results, your meter also stores all relevant additional information and display messages. For example, results flagged as control results are displayed together with a bottle symbol incorporating the letter “C”. Results obtained at a temperature outside the permitted range are displayed together with a thermometer symbol. Please refer to Chapter 8 for a complete list of display messages and symbols. 61 man_04493168001_02_EnUK.
5.2 Retrieving results 62 man_04493168001_02_EnUK.
To use the memory functions of your Accu-Chek Active meter, you must turn it on in Memory Mode. 씰 Briefly press the M button (for less than 3 seconds). In the display you see the following: 씰 at top left, “mem” (short for “memory”) 씰 followed by the most recent result (in memory location “1”), together with the time and date. 63 man_04493168001_02_EnUK.
5.2 Retrieving results 64 man_04493168001_02_EnUK.
To recall earlier results (in memory locations 2-200): 씰 Press the S button once to move back one result in time. As long as you keep the button pressed, the number of the memory location is displayed. As soon as you release the button, the result appears. 씰 By holding down the S button, you can scroll quickly through the results. As soon as you release the button, the result saved in that location appears.
5.2 Retrieving results 66 man_04493168001_02_EnUK.
Finding the 7 or 14 day average of glucose results As well as just showing the results in memory, your Accu-Chek Active meter can calculate and display average values for the last 7 or 14 days. 씰 Start by pressing the M button to turn on your Accu-Chek Active meter in Memory Mode. 씰 Then press the M and S buttons at the same time. The display shows “7 day ave” at top right. The figure shown is the average of glucose results for the last 7 days. 67 man_04493168001_02_EnUK.
5.2 Retrieving results 68 man_04493168001_02_EnUK.
씰 Then press the M and S buttons again at the same time. 씰 The display changes; the figure shown is now the average value for the last 14 days. To exit from the “average” screen, press the S button. The display reverts to the last result shown before the average value. Averages can only be calculated as long as you have set the date and time (see Chapter 3.2). Without these settings the meter cannot identify the results from the last 7 or 14 days.
5.2 Retrieving results longer than 3 seconds 70 man_04493168001_02_EnUK.
Clearing (erasing) results from memory You can clear the current value (and only this) from memory. This feature is useful, for instance, if you have obtained an implausible result. Both the result and the time and date information are erased, though the memory location remains occupied. An average value cannot be displayed when the most recent result has been erased from memory. Results arising after a value has been erased are included in calculation of the average.
5.2 Retrieving results longer than 3 seconds longer than 5 seconds 72 man_04493168001_02_EnUK.
씰 Keep the M and S buttons pressed together for longer than 3 seconds. 씰 The current result is displayed. 씰 Keep the M and S buttons pressed together for longer than 5 seconds. You will hear 5 beeps. 씰 All information relating to the current result is cleared and set to zero. The memory location remains occupied. Your Accu-Chek Active meter turns off automatically after you have cleared the result. 73 man_04493168001_02_EnUK.
5.3 Downloading data to a PC General information about data downloading Roche Diagnostics offers a variety of special software programs (e.g. Accu-Chek Compass, and the Accu-Chek Smart Printer System) to expand the memory functions integrated in your Accu-Chek Active meter. Such programs enable you and your doctor to manage your data more effectively and, through graph and table views, make it easier for you to understand your self-testing data.
For data downloading you need a suitable PC program as well as the Accu-Chek Infrared Cable. For further information please contact the Accu-Chek Customer Careline 0800 701000 (UK) or 1 800 709600 (Ireland) (see Chapter 10.4). Data can only be evaluated on a PC as long as you have set the full date and time (see Chapter 3.2). Your Accu-Chek Active meter has an inbuilt infrared interface 11 (see illustration on pages 6–7), permitting cordless data downloading to a suitably equipped PC.
5.3 Downloading data to a PC longer than 3 seconds 76 man_04493168001_02_EnUK.
Downloading procedure To download data, proceed as follows: 씰 Set up the program and infrared cable according to manufacturer’s instructions so you can start data transfer with a mouse click. 씰 Position your Accu-Chek Active meter about 10 cm from the infrared cable. Point the two infrared windows towards one another. 씰 Turn on your Accu-Chek Active meter by keeping the M button pressed (for longer than 3 seconds) until “PC” appears flashing in the display.
5.3 Downloading data to a PC 78 man_04493168001_02_EnUK.
씰 Start downloading at the PC. The PC sends an instruction to the Accu-Chek Active meter. 씰 During active downloading, “PC” remains constant in the display 씰 On completion of downloading, “End” appears in the display. Following the download you can turn off your Accu-Chek Active meter with the M button, if the PC has not already shut down the meter. In the latter case the “End” message may not be displayed. 79 man_04493168001_02_EnUK.
6 Checking Accu-Chek Active 6.1 Quality control testing with control solution To ensure your results are always dependable, you must periodically check the performance of your Accu-Chek Active meter. Perform a quality control test: 80 man_04493168001_02_EnUK.
씰 after you have opened a new pack of Accu-Chek Active test strips and consequently replaced the coding chip, 씰 after you have inserted a new battery, 씰 after you have cleaned your Accu-Chek Active meter, 씰 if you have reason to doubt the validity of a result. 81 man_04493168001_02_EnUK.
6.2 Preparing for the quality control test 82 man_04493168001_02_EnUK.
For the quality control test, please have the following items ready: 씰 your Accu-Chek Active meter with the coding chip inserted, 씰 the pack of Accu-Chek Active test strips you took the coding chip from, 씰 the Accu-Chek Active Control solutions. Carefully read the pack inserts that came with the test strips and the control solutions, and select a control solution. 83 man_04493168001_02_EnUK.
6.3 Quality control test procedure 씰 Remove a test strip from its container. Close the container immediately. The cap contains a drying agent which ceases to function if the container is left open, rendering the test strips unusable. 씰 Check the round control window on the back of the test strip against the colour scale printed on the test strip container. The colour of the control window must match that of the colour interval at the top (0 mmol/L).
씰 Hold the test strip so that the application area and arrows are facing upwards. Gently push the test strip in the direction of the arrows into the test strip slot ➃ of your Accu-Chek Active meter, until you hear it click into place. Inserting the test strip automatically puts the meter in Test Mode. Please remember that your Accu-Chek Active meter automatically turns off after about 1–2 minutes of non-use (i.e. when no button is pressed).
6.3 Quality control test procedure 86 man_04493168001_02_EnUK.
씰 The meter performs a display test lasting 2 seconds. Check that all the segments making up the numerals (“888” or “88.8”) are properly displayed. If a segment is missing, test results may be displayed inaccurately (e.g. through 9 being confused with 3). If this happens, call your customer support and service centre. 씰 The current code number then appears in the display. Is this the number printed on the test strip container? If not, check that you really did insert the coding chip from the new pack.
6.3 Quality control test procedure 88 man_04493168001_02_EnUK.
When the display test has been successfully completed and the code number matches, your Accu-Chek Active meter is ready for testing. The display screen that follows signals: 씰 That the test strip has been inserted. 씰 The flashing drop symbol is your cue to apply the control solution (blood in the case of a real test). To make quality control results stand out later from blood glucose test results, you can place what is known as a “flag” against them. 씰 Press the S button once.
6.3 Quality control test procedure 90 man_04493168001_02_EnUK.
씰 Apply one drop of the selected control solution to the test pad of the strip. 씰 Your Accu-Chek Active meter beeps briefly to acknowledge application of solution and to announce the start of testing. 씰 After 5 seconds a second beep tone indicates that testing is complete, and the result appears in the display. If you have not already flagged this quality control result, you may do so now. The value displayed here is an example. The result shown on your Accu-Chek Active meter will not necessarily agree.
6.3 Quality control test procedure ACCU-CHEK® Active Control mg/dL 1 36 – 66 2 131 – 177 mmol/L 2,0 – 3,7 7 ,3 – 9,8 Values are for illustration only. Now check that the displayed value is within the permitted range. Examine the test strip container and locate the “Accu-Chek Active Control” table. The table has two rows listed as “1” and “2”, as well as two columns giving ranges in mmol/L and mg/dL. 92 man_04493168001_02_EnUK.
씰 If you performed the test with Accu-Chek Active Control 1, refer to row 1 for the permitted range. 씰 If you performed the test with Accu-Chek Active Control 2, refer to row 2 for the permitted range. If the result is within the stated range, you need to still carry out a visual plausibility test. It is important that this check be performed within 30–60 seconds after control solution was applied.
6.3 Quality control test procedure 94 man_04493168001_02_EnUK.
씰 Turn over the test strip to reveal the round control window on the back. 씰 On the label of the test strip container is a colour scale with blood glucose values printed alongside. Select the blood glucose value that best approximates the reading you obtained. 씰 Compare the colour of the control window with the colour you selected on the label. The colours must be a fairly close match. If there is a great disparity, repeat the test.
6.4 Performing a full display check longer than 3 seconds 96 man_04493168001_02_EnUK.
The standard power-on display test checks the most important display elements. To verify that all of the elements are functioning correctly, you can carry out a full test. 씰 Press and hold down the M and S buttons together for longer than 3 seconds. 씰 All the elements of the liquid crystal display (LCD) are shown at once. Either “mmol/L” or “mg/dL” will be visible depending on the country-specific setting. 씰 Press any key to terminate the display test and turn off your Accu-Chek Active meter.
7 Keeping your meter in tip-top condition Your Accu-Chek Active meter has no moving parts and so will not suffer any mechanical wear and tear. As with any precision instrument, however, you will need to look after it carefully to keep it at its best. 98 man_04493168001_02_EnUK.
7.1 Cleaning your Accu-Chek Active meter Accu-Chek Active utilises an optical measuring method that relies heavily on all of its components being clean. Be sure to clean the meter, therefore 씰 whenever it is showing signs of soiling, however slight (especially on the test strip guide or the measurement optics located below it), 씰 whenever you open a new pack of test strips, 씰 every 2 months at the latest. 99 man_04493168001_02_EnUK.
7.1 Cleaning your Accu-Chek Active meter 100 man_04493168001_02_EnUK.
Clean the measurement optics carefully with nothing other than cold water, soft lint-free cloths and cotton swabs. For disinfection you may use 70 % alcohol. Any other cleaning agents may damage the meter or impair its measuring function. 씰 Slide off the test strip guide towards you (see illustration). 씰 After removal of the test strip guide from the meter, clean it with cold water. 씰 Afterwards you may wipe the test strip guide with 70% alcohol.
7.1 Cleaning your Accu-Chek Active meter 102 man_04493168001_02_EnUK.
씰 Wipe the measurement optics components with a soft lint-free cloth and/or a cotton swab. The cloth/cotton swab may be slightly moistened with water or 70% alcohol. Make sure that no liquid enters the meter itself. Avoid scratching the measurement optics, as this will impair the measuring function. 씰 When all of the components are thoroughly dry, you may slide the test strip guide back onto the meter. Ensure it clicks back into place.
7.1 Cleaning your Accu-Chek Active meter Cleaning and disinfection in the professional environment Be sure to observe all relevant Health and Safety regulations. A potential infection risk exists. Medical staff and other persons using Accu-Chek Active to test blood glucose from more than one patient must be aware that any item coming into contact with human blood is a potential source of infection.
For cleaning use only cold water and cotton swabs. 6 % formaldehyde solution may be used for disinfection. Please take into account the time it takes for the agents used to act. Any other cleaning agents may damage the meter or impair its measuring function. 105 man_04493168001_02_EnUK.
7.2 Battery life and battery replacement 106 man_04493168001_02_EnUK.
A new battery provides enough power for about 1,000 tests. When you first see the battery symbol displayed, there is still enough power for about 50 tests, though we recommend that in this event you replace the battery as soon as possible. By then the battery will have been considerably drained, and changeable conditions (cold surroundings) can affect its performance even further. Insert a new battery into the meter as follows: 씰 Turn your Accu-Chek Active meter over.
7.2 Battery life and battery replacement 씰 Slide the battery compartment back into the meter and press gently inwards until it clicks home. 씰 After replacing the battery, check the performance of the monitor as described in Chapter 6. If you complete the replacement within about 1 minute, the date and time settings will be retained. All of the other results will be retained however long it takes to replace the battery. Think of the environment.
7.3 Measurement and storage conditions When testing blood glucose, pay close attention to the following points. They affect the dependability of your Accu-Chek Active meter and the accuracy of your results. Temperature range 씰 For performing blood glucose tests the permitted range is from +10 °C to +40 °C. 씰 A test can be performed at the limits of the permitted range (between +5 °C and +10 °C or +40 °C and +45 °C), but the result should be interpreted with caution.
7.3 Measurement and storage conditions Do not use results obtained at the limits of the permitted temperature range as a basis for therapeutic decisions. Never try to speed up warming or cooling of your Accu-Chek Active meter artificially (e.g. by placing it on a radiator or in a refrigerator). Doing so can damage your meter and cause it to give incorrect results. Light conditions 씰 Do not carry out a test where the meter and test strips are exposed to direct sunlight.
Atmospheric humidity 씰 Relative humidity must be below 85%. 씰 Sudden changes in temperature cause condensation within the meter. You may find you are unable to turn on your Accu-Chek Active. Allow the meter to return slowly to room temperature, and never keep it in a room that is likely to harbour condensation (e.g. a bathroom). Sources of interference 씰 Strong electromagnetic fields may interfere with the proper operation of the meter.
8 Summary: All the display messages on your Accu-Chek Active meter 8.1 About the display messages When you use your Accu-Chek Active meter, various letters and symbols will appear on the display, at times also error messages. Some of these display messages, those occurring in routine use, have already been explained. We now present a complete list of display messages, what they mean, and what action you should take in case you see an error message.
8.2 Messages and symbols This message appears ... and means: ● in Memory Mode ● ● (flashing) when a result is being cleared ● This is a value saved in memory. You are in the process of clearing a value from memory. ● after the display test in association with the code number (flashing) after the display test in association with “---” ● Check the code number. ● The coding chip is missing.
8.2 Messages and symbols This message appears ... and means: in Test Mode when the result is displayed (Test and Memory) ● ● The ambient temperature is/was close to the limit at the time of testing. Do not use the result as a basis for therapeutic decisions. ● in all modes ● When this symbol first appears, the battery still has power for about 50 tests. Replace the battery at the earliest opportunity. ● 114 man_04493168001_02_EnUK.
This message appears ... and means: ● during testing ● The test is in progress. ● during testing, when enabled attached to results in memory ● This is/was a quality control test. ● in Memory Mode ● The figure is the 7/14 day average. ● in Set Mode ● The beep tone is enabled. ● 115 man_04493168001_02_EnUK.
8.2 Messages and symbols This message appears ... and means: ● in Test Mode ● The light is too bright, testing is not possible. Please move to another location. ● (flashing) in Test Mode ● Apply a drop of blood now. ● in Test Mode ● ● (flashing) in Test Mode ● The test strip is inserted. Re-insert the test strip (out-of-meter testing). 116 man_04493168001_02_EnUK.
8.3 Troubleshooting This error message means ... The test strip has been inserted incorrectly. Insert the strip, test pad upwards, in the direction indicated by the arrows, until it snaps into place. The wrong coding chip is inserted. This coding chip does not belong to Glucose test strips from the Glucotrend or Accu-Chek Active blood glucose systems. Remove this coding chip, insert the correct coding chip. The coding chip cannot be read. Remove the chip and re-insert it.
8.3 Troubleshooting Measurement optics error. Clean the measurement optics (Chapter 7.1). Check that the test strip is lying flat and straight in the test strip guide. If the message persists, the meter has a fault. Please call your customer support and service centre. Although rarely occuring - you applied too little blood to the strip. Repeat the test with a new Accu-Chek Active test strip. The measurement optics are dirty or you have inserted a test strip that has already been used or is expired.
The test strip was not fully inserted, was moved during testing, or was dosed with blood too soon. Repeat the test with a new test strip and ensure that it snaps into place. The coding chip is missing or has a fault. The Accu-Chek Active meter has a fault and cannot be used. Please call your customer support and service centre. You applied too little blood to the test strip, or the test strip was not lying flat and straight in the test strip guide. Repeat the test with a new test strip.
8.
씰 Are the test strips and/or control solution still within the stated expiry date? 씰 Have you cleaned your Accu-Chek Active meter (especially the test strip guide and measurement optics) as instructed in Chapter 7.1? 씰 Have you used only test strips with a code number matching that displayed by the meter? If you have observed all these points and still are having problems, please contact the Accu-Chek Customer Careline. 121 man_04493168001_02_EnUK.
On the finger pricker itself and on the packaging of Accu-Chek Softclix Lancet you may encounter the following symbols, shown here with their meaning: Please read this note with special care 2 For single use only The lancets may only be used up to the expiry date specified on the box. Lot number LOT STERILE R 0088 The lancets have been sterilised with at least 25 kGy This product fulfils the requirements of Directive 93/42/EEC of 14th June 1993 on medical devices. 122 man_04493168001_02_EnUK.
9 Accu-Chek Softclix Introduction Accu-Chek Softclix 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 Accu-Chek Softclix finger pricker is intended for patient self-monitoring by a single person. It must not be used to collect blood in a multi-patient setting as it does not incorporate any features to guard against cross-infection.
9.1 The Accu-Chek Softclix at a glance A Cap B Comfort Dial (for selecting penetration depth) 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 124 man_04493168001_02_EnUK.
A B C D E G F H I J 125 man_04493168001_02_EnUK.
9.2 Selecting the penetration depth of your Accu-Chek Softclix finger pricker Depth of penetration should be selected so that only the amount of blood necessary for testing is obtained. For this purpose Accu-Chek Softclix 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 to suit individual skin type.
Number 0.5 corresponds to the smallest depth of penetration and number 5.5 the greatest. When selecting the individual penetration depth it is recommended to start with level 1 or 2 to see if the amount of blood obtained is enough to carry out the test. Thicker skin will require a higher level. Recommended Penetration Settings • 0.5-1.5 for soft skin • 2-3.5 for normal skin • 4-5.5 for thicker skin 127 man_04493168001_02_EnUK.
9.3 Using the Accu-Chek Softclix finger pricker 1. Pull off the Accu-Chek Softclix cap. Insert a new Accu-Chek Softclix lancet in the lancet holder and push it in until it clicks. Remove the protective cap from the lancet with a twisting motion. To avoid injuries, keep cap and replace on lancet before discarding. Use a new lancet each time you take blood to prevent infection and to ensure virtually painless blood sampling. 2. Press the Accu-Chek Softclix cap on again until it clicks.
5. Gently press the Accu-Chek Softclix finger pricker against the side of the fingertip or earlobe and press the release button. Take care not to push against the priming button or to impede its free movement. Wait a few seconds to allow a droplet of blood to form or gently squeeze the fingertip to develop a drop of blood. Gently touch the front edge of the test strip against the blood. If you do not obtain sufficient blood, try the test again with progressively higher settings.
9.3 Using the Accu-Chek Softclix finger pricker Selecting the Puncture Site The best place to take capillary blood is from the side of a fingertip as it has the best blood supply and registers the least pain. Preparing Fingertip or Earlobe Wash your hands in warm water and dry them well. This helps ensure proper hygiene and stimulates blood flow, since the drop may be too small if the finger to be pricked is too cold or circulation is poor. In addition finger or earlobe should be massaged before pricking.
Safety Remarks Only use a Softclix lancet with the Accu-Chek Softclix device since the use of other lancets may prevent or impair proper function of Accu-Chek Softclix. Important note for Healthcare Professionals: If handling devices returned after use by patients, please ensure that the patient has removed the used lancet from Accu-Chek Softclix prior to handling the device. 131 man_04493168001_02_EnUK.
10 Appendix 10.1 Technical data Meter type Accu-Chek Active 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 Active test strips. Measuring range 0.6–33.3 mmol/L Measuring time approx.
Automatic power-off 1–2 minutes after last button press Power supply 1 lithium battery type CR2032 or type DL2032 Battery life approx. 1,000 tests in one year Safety class III Interface infrared interface, LED/IRED Class 1 System operating temp. 10 – 40 °C Atmospheric humidity up to 85% relative humidity Storage temperature –40 °C to +70 °C Electromagnetic compatibility This device meets the electromagnetic immunity requirements as per ISO 15197 Annex A.
10.2 System components With your Accu-Chek Active meter use only Accu-Chek Active test strips. These are available from your pharmacist. For quality control testing of your Accu-Chek Active meter use only Accu-Chek Active Control solutions (see Chapter 6). For virtually pain-free blood sampling we recommend the Accu-Chek Softclix finger pricker and Accu-Chek Softclix Lancet lancets. These are available in the following pack size: 씰 200 Accu-Chek Softclix Lancet 134 man_04493168001_02_EnUK.
For healthcare professionals we recommend the Accu-Chek Softclix Pro finger pricker and special lancets Accu-Chek Softclix Pro Lancet, or Safe-T-Pro disposable lancet devices. All of the system components are carefully matched. With your Accu-Chek Active meter use only Accu-Chek Active test strips. Any other test strips will give incorrect results. Sometimes the error can be significant, causing the wrong therapeutic decision to be taken and so producing adverse health effects.
10.3 Manufacturer’s warranty and guarantee Manufacturer’s warranty: As part of the Accu-Chek Commitment, Roche Diagnostics warrants that the meter and finger pricker shall be free from detects in material and workmanship under the terms as specified on the warranty card. Your statutory rights are not affected. The meter and finger pricker must have been subjected to normal use.
Guarantee: The manufacturer’s warranty is in addition to, and in no way affects, your statutory rights or any warranty claims you may have against the seller of the meter under the terms of your sales contract. Be sure to fill out your warranty card that came with your Accu-Chek Active system and return to Roche Diagnostics. 137 man_04493168001_02_EnUK.
10.4 Customer support and service Customer support and service Customer support: If you have any questions on how to use your meter or finger pricker, if any of the results you obtain seem implausible, or if you suspect the meter has a fault, please contact the Accu-Chek Customer Careline. Service: Please note that any repair, adjustment, or other change of the meter must only be performed properly by persons who have been authorised by Roche Diagnostics.
11 Alphabetical index Accu-Chek Softclix Ambient temperature Atmospheric humidity Average value Battery Battery capacity Blood application Blood collection Causes of error Cleaning the meter Coding Coding chip Colour comparison Colour scale Control solution Control value Control window Customer support Data downloading Display Display test, full Disposal Drop symbol 123ff. 114, 119 111, 133 10, 67ff., 93, 115 5, 18, 81, 106ff. 11, 114, 133 10, 43ff., 55ff., 59, 116 37, 44, 55, 128 120ff. 99ff. 10, 32ff.
Electromagnetic interference Enabling and disabling the beep tone Erasing results Error messages/error symbols Finger pricker Infrared cable Infrared interface Interferences Leap year Light conditions Measurement optics Measuring blood glucose Measuring conditions Measuring principle/measuring procedure Measuring range Measuring time Memory Mode Notebook, electronic Parts summary Plausibility check Practising testing Quality control test Retrieving results 111, 118 31 71ff. 112-119 36, 44, 55, 59, 124ff.
Sample material Saving results Service Set Mode Setting the date Setting the time Setting the year Shut-off time Shut-off, automatic Special testing situations Storage conditions Sun symbol Symbols System components Technical data Temperature range Test strip guide Testing by healthcare professionals Thermometer symbol Turning on Underdosing Units Warnings 132 60ff. 138 17, 23ff 25ff. 25ff. 29 11, 39, 85, 133 47, 73, 93, 97, 133 55, 59 109ff., 120 110, 116 11, 112, 113ff. 134ff. 132ff. 61, 109ff.
0088 ACCU-CHEK and SOFTCLIX are trademarks of Roche. Distributed by: Roche Diagnostics Limited Charles Avenue, Burgess Hill West Sussex, RH15 9RY www.accu-chek.co.uk UK Freephone number: 0800 701 000 ROI Freephone number: 1 800 709 600 Roche Diagnostics GmbH D-68298 Mannheim, Germany www.accu-chek.com man_04493168001_02_EnUK.indd u2 0 4493168001(02) 2006-11 © 2006 Roche Diagnostics. All rights reserved.